TO0001PWS_AttachL_DMLSSMigrationReference.xlsx
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Task Order 0001 PWS Attachment L
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Centralized Device Code
| Device | Nomenclature | Class Code | Class Nomenclature | FSC | Spec | Risk | AEC | Life | MRI | IN | PM | CAL | SPR | INSP Mob | PM Mob | CAL Mob | SPR Mob | Low Price | High Price | Definition |
| 24553 | ABERROMETER | 24553 | ABERROMETERS | 6540 | OPT | 4 | L | 10 | N | Ophthalmic measuring instruments designed for determining aberration by measuring the direction of light rays reflected from the eye and reconstructing the wavefront. Instruments that use several different technologies are available. An instrument based on the Hartmann-Shack principle consists of a light source (most often a laser); a wavefront sensor, made of a array of micro-lenses (known as lenslets) that spilt the wavefront into a number of light spots to be focused on a charge-coupled device (CCD) camera; computer data processing capabilities and a display for the result. Other aberrometers use the ray tracing principle and consist of a light source (most often a laser), a lens system, an x-y scanner, a beam splitter, and a photodetector to project a series of beam of light into the eye sequentially and to capture the retinal images of the light. Aberrometers are mainly used to plan laser refractive surgery and for lens fitting. | ||||||||||
| 15810 | ACCELEROMETER | 15810 | ACCELEROMETERS | 6680 | ENG | 4 | L | 7 | N | $1,400.00 | $3,000.00 | Devices designed to measure the rate of change of an object's velocity. These devices typically consist of a sensor and transducer, an amplifier, and extension cables for connection to an electronic measuring unit. They work on the principle of seismic mass: this mass is restrained by a spring, and when the transducer case is accelerated, the mass moves relative to the case and exerts a force on the spring. The acceleration is calculated by measuring mass displacement or the mass' force on the spring, converted to an electrical signal. Acceleration transducers are available using strain gauges (e.g., metallic foil, piezoresistive), capacitive elements, and piezoelectric elements. Clinical accelerometers are intended for several purposes, including measuring the acceleration of body parts to assess a patient's mobility and/or activity (alone or as a component of activity monitors and gait analyzers respectively); assess tremor (e.g., in patients with Parkinson's disease); and activate pacemakers according to the patient's position (e.g., upright). | ||||||||
| 16353 | ACRYLIC CURING UNIT, DENTAL | 16353 | ACRYLIC CURING UNITS, DENTAL | 6520 | DEN | 4 | L | 8 | Y | 12 | 12 | 12 | 12 | 0.0 | 0.0 | Devices used to provide heat- or cold-curing of the base resins that comprise most acrylic dentures. | ||||
| 10024 | ADAPTOMETER | 10024 | ADAPTOMETERS | 6540 | OPT | 4 | L | 9 | N | 0.0 | 0.0 | Ophthalmic measuring instruments designed to determine dark adaptation by providing a stimulating light source that has varying controlled intensities. The devices usually consist of a computerized control panel, light sources, a test unit, and a response recording mechanism to provide light stimuli of varying brightness to the subjects. Adaptometers are used for detection of night blindness and its associated underlying conditions, as well as other eye problems. | ||||||||
| 10045 | AERATOR, ETHYLENE OXIDE | 10045 | AERATORS, ETHYLENE OXIDE | 6530 | HF | 4 | Y | 12 | Y | 12 | 12 | $6,400.00 | $16,000.00 | Equipment that includes an enclosure (e.g., a cabinet) equipped with mechanisms appropriate for rapid reduction of residues of ethylene oxide (EtO) from the surfaces of EtO-sterilized devices. | ||||||
| 10046 | AEROSOL GENERATOR | 10046 | AEROSOL GENERATORS | 6515 | ANE | 2 | Y | 8 | Y | 6 | 12 | 12 | 12 | 12 | 0.0 | 0.0 | Devices designed to produce (i.e., generate) gaseous suspensions of extremely small particles of a liquid or solid. These generators typically include a micro-ultrasonic, or pneumatic pumping mechanism capable of creating a fine-particle liquid mist appropriate for delivery to the patient's airways and/or for lung deposition. Aerosol generators are available in a variety of sizes and configurations according to the clinical procedure and/or the device used for aerosol delivery; they are usually connected through flexible hoses or tubes to face masks, ventilator breathing circuits, or aerosol tents. Some generators are an integral part of fixed and/or portable nebulizers. Aerosol generators are used mainly to produce an aerosolized mist from saline solutions and drug formulations; some dedicated devices are intended to produce a radioactive particle aerosol. . | |||
| 20709 | AIR CLEANER, PARTICULATE | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | 0.0 | 0.0 | Air cleaners designed to remove particulates (e.g., smoke, biological aerosols) from the room air. These cleaners typically include a combination of filters (e.g., a coarse pre-filter and a very fine particle filter), intake and exhaust ducts, a motor blower assembly, and a control panel that includes an airflow speed control, a manometer to measure the pressure across the filter and/or a filter-change indicator. Some devices remove the particles by electrostatic attraction and capture (i.e., electrostatic precipitation) of the particles instead of filtering. Particulate air cleaners are used in healthcare facilities to reduce the concentration of biological airborne infections and allergens. | ||||
| 18114 | AIR CLEANER, PARTICULATE, ELECTROSTATIC PRECIPITATION | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | $800.00 | $1,500.00 | Particulate air cleaners designed to remove particles from the air by electrostatic attraction and capture (i.e., precipitation) of the particles. Positively charged ions are attracted to airborne particles as they are drawn through the unit; the positively charged particles are then precipitated from the air as they pass through a negatively charged panel or a series of plates. The electrostatic charge should be supplied by an appropriate electrical power source. | ||||
| 18115 | AIR CLEANER, PARTICULATE, ELECTROSTATIC PRECIPITATION, MOBILE | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | $700.00 | $1,500.00 | Electrostatic precipitation filter air cleaners mounted on wheeled platforms and specially designed for mobile applications. These cleaners are intended for movement from one location to another in a healthcare facility, they may be also used in modular medical facilities (both stationary and mobile) and in emergency shelters. | ||||
| 18112 | AIR CLEANER, PARTICULATE, HIGH-EFFICIENCY FILTER | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | $1,800.00 | $5,600.00 | Devices designed to remove very fine particles from the air, typically 99.97% of particles bigger than 0.3 micron. These cleaners usually combine a low-efficiency prefilter and a high-efficiency particulate-air (HEPA) filter. HEPA cleaners can create very-low-particulate environments in healthcare facilities (e.g., laboratories, isolation rooms) and remove bacteria (e.g., those causing tuberculosis) from the environment. HEPA cleaners can remove most aerosolized biological agents and radioactive particles. | ||||
| 18113 | AIR CLEANER, PARTICULATE, HIGH-EFFICIENCY FILTER, MOBILE | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | $500.00 | $7,000.00 | High efficiency particulate filter air cleaners mounted on wheeled platforms and specially designed for mobile applications. These cleaners are intended for movement from one location to another. In a healthcare facilities, modular medical facilities (both stationary and mobile), and in emergency shelters they may be used to protect from toxic industrial contaminants and biological agents or radioactive particulates. | ||||
| 20710 | AIR CLEANER, PARTICULATE/GAS/VAPOR | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | $259.00 | $25,000.00 | Air cleaners designed to cleanse room air by removing particulates and gas/vapors from the air and then recirculating the cleansed air. These cleaners typically include a set of filters to remove particulates and gas/vapors; depending upon the characteristics and efficiency of the filter(s) they can remove airborne particulates (aerosols) such as aerosol bacteria, other biological agent particulates, or radioactive particles; and/or gases and vapors including toxic industrial contaminants and chemical and biological agents. Particulate and gas/vapor air cleaners are used in healthcare facilities, isolation and clean rooms, and emergency shelters. | ||||
| 20712 | AIR CLEANER, PARTICULATE/GAS/VAPOR, CHEMICAL AGENT | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | 0.0 | 0.0 | Particulate/gas/vapor air cleaners designed to remove very fine particulate from the air, typically 99.97% of particles bigger than 0.3 micron, and also chemical agents (e.g., nerve, blister) in gas or vapor phase from the air stream. These cleaners usually include a combination of a low-efficiency pre-filter, a high efficiency particulate air (HEPA) filter, and one or more gas sorbent filters according to the expected chemical agent and the prevalent conditions (e.g., contaminant concentration, molecular weight and size, temperature). Chemical agent air cleaners are used in air cleaning systems designed for permanent facilities and/or in temporary emergency shelters in areas contaminated and/or potentially contaminated with chemical agents. | ||||
| 23920 | AIR CLEANER, PARTICULATE/GAS/VAPOR, GERMICIDAL | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | $500.00 | $10,000.00 | Air cleaners designed to remove airborne aerosol microorganisms and other biological agent particulates from room air, possibly by applying radiation (e.g., ultraviolet [UV] light). These cleaners typically include a set of fine filters to remove particulates (e.g., 99.97% of particles bigger than 0.3 micron), including airborne particulates (aerosols) with bacteria and other biological agents. Germicidal air cleaners are intended for continuous use in healthcare facilities, including waiting rooms and doctors' offices. Dedicated germicidal air cleaners, which use UV light radiation that can kill most bacteria and many virus types, are also available. | ||||
| 23419 | AIR CLEANER, PARTICULATE/GAS/VAPOR, GERMICIDAL, ULTRAVIOLET LIGHT | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | $1,000.00 | $10,000.00 | Germicidal air cleaners designed to kill most bacteria (e.g., Mycobacterium tuberculosis) and many virus types using ultraviolet (UV) radiation. These devices are typically enclosed metal (usually stainless steel) air cleaners with UV (radiation at 254 nm is typical) lamps, particulate filters, fans, and switches. UV germicidal air cleaners are intended for continuous use in healthcare facilities, including waiting rooms and doctors' offices, especially where ceiling height or other conditions do not allow the installation of UV lamps higher than 7 feet; the devices are less effective against fungus and bacteria spores. | ||||
| 20711 | AIR CLEANER, PARTICULATE/GAS/VAPOR, TOXIC INDUSTRIAL CONTAMINANT | 16629 | AIR CLEANERS | 6530 | PUL | 3 | Y | 15 | Y | 12 | 12 | 12 | 12 | $259.00 | $25,000.00 | Particulate/gas/vapor air cleaners designed to remove very fine particulate from the air, typically 99.97% of particles bigger than 0.3 micron, and also toxic industrial contaminants (TIC's) in gas or vapor phase from the air stream. These cleaners usually include a combination of a low-efficiency pre-filter, a high efficiency particulate air (HEPA) filter, and one or more gas sorbent filters according to the expected industrial contaminants and the prevalent conditions (e.g., contaminant concentration, molecular weight and size, temperature). TIC air cleaners are used in air cleaning systems designed for permanent facilities and/or in temporary emergency shelters during industrial accidents. | ||||
| 20672 | AIR PRESSURE THERAPY UNIT, MIDDLE EAR | 20672 | AIR PRESSURE THERAPY UNITS, MIDDLE EAR | 6530 | AUD | 3 | Y | 8 | Y | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Air pressure units (i.e., generators) designed for treatment of excess fluid volume and pressure in the middle ear (i.e., Meniere's disease). These devices consist of a low-pressure generator that delivers low-frequency, low-amplitude pressure pulses to the middle ear through a ventilation tube that was previously implanted into the patient's eardrum, between the external canal and the middle ear. The device administers automatically controlled pulses of air to increase the pressure within the middle ear, reducing fluid pressure in the inner ear. Middle ear pressure therapy units are used to alleviate the symptoms of Meniere's disease when other clinical treatments (e.g., administration of drugs) have failed. | ||||
| 20738 | AIRWAY CLEARANCE UNIT, HIGH-FREQUENCY CHEST WALL OSCILLATION | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Airway clearance units designed to apply automated mechanical oscillation to the chest wall to obtain a high-frequency oscillation (HFO) of the air column in the conducting airways. These devices may use one of several techniques to provide the oscillation, including external percussion on the chest wall, intermittent compression by a patient-worn vest, and a cycle of positive and negative pressure compression provided by a cuirass around the patient chest. High-frequency chest wall oscillation units are intended to shear mucus from the airway wall by oscillatory forces and to aid in mucus mobilization and expectoration; some units are capable of providing mechanical ventilation of patients. Devices that perform chest wall oscillation using a cuirass may also act as mechanical ventilators. | ||
| 20741 | AIRWAY CLEARANCE UNIT, HIGH-FREQUENCY CHEST WALL OSCILLATION, CUIRASS | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Airway clearance units designed to applied high-frequency oscillation (i.e., compression) to the chest wall using an external, flexible chest enclosure (a cuirass, similar to those used in negative pressure ventilators), delivering noninvasive oscillation (i.e., cycles of positive and negative pressure) to the airways and lungs. These devices typically include an electrically powered oscillator that is controlled using a microprocessor. The expiratory pressure may be positive, atmospheric, or negative, permitting ventilation above, at, or below the patient normal residual capacity; frequency may be typically controlled in the range of -70 to +70 cm of water and pressure from 8 to several hundred oscillations/minute. Cuirass airway clearance units are intended for administration of therapy for mucus clearance and sputum induction; they may be used also to provide mechanical ventilation to some patients. | ||
| 20739 | AIRWAY CLEARANCE UNIT, HIGH-FREQUENCY CHEST WALL OSCILLATION, PERCUSSION | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Airway clearance units designed to apply automated external percussion to the chest to obtain a high-frequency oscillation (HFO) of the air column in the conducting airways. These units are usually pneumatic powered; the percussion is applied to the chest typically at frequencies between 13 and 15 Hz (close to the natural harmonic frequency of the chest wall). They are used mainly to facilitate secretion removal in vulnerable patients, especially those suffering from cystic fibrosis and other pulmonary, neuromuscular, or neurological disorders that affect normal secretion of mucous from the airways. | ||
| 20740 | AIRWAY CLEARANCE UNIT, HIGH-FREQUENCY CHEST WALL OSCILLATION, VEST | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Airway clearance units designed to applied non-invasive, high-frequency oscillation (i.e., compression) to the chest wall using a vest. These devices typically consist of large-volume variable-frequency air-pulse delivery unit attached to a non-stretchable inflatable vest worn by the patient and that extends over the entire torso. The pressure (in a range from 28 to 39 mm of H20) is applied by the vest either during all the respiratory cycle or only during expiration, in pulses which frequency is controlled by the patient typically in a range from 5 to 25 Hz. Vest units are intended for self-administration of therapy for mucus clearance and sputum induction in patients with chronic obstructive pulmonary diseases. | ||
| 20459 | AIRWAY CLEARANCE UNIT, INSUFFLATION/EXSUFFLATION | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Airway clearance units designed to apply low-frequency cycles of a gradually increasing positive pressure (e.g., 20 to 30 cm H20) to the airways followed by a rapid change to a negative pressure (typically negative 30 to negative 40 cm H20), exhausting the lungs and reproducing in the bronchial tree the effects of a vigorous cough. These devices typically consist of a portable electric unit that provides the positive and negative pressures and that includes automated and/or manual controls and timers to perform the inspiratory and expiratory cycles; and a patient breathing circuit that includes a bacterial filter, breathing tubes; and a patient interface (e.g., a mask, mouthpiece, tracheostomy tube adapter). Insufflation/exsufflation units are intended to palliate respiratory deficiency in patients with debilitated respiratory muscles and/or other disorders that affect the respiratory function, such as spinal cord injuries, muscular dystrophy, amyotropic lateral sclerosis, and poliomyelitis. | ||
| 20737 | AIRWAY CLEARANCE UNIT, OSCILLATORY INTRAPULMONARY PERCUSSION | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Airway clearance units designed to perform high-frequency airway oscillation of the air column in the conducting airways by applying high-flow mini-bursts (similar to those provided by high-frequency ventilators) to the airway opening during both inhalation and exhalation. During these percussive bursts of gas a continuous positive airway pressure is usually maintained while the pulsatile percussive airway pressure increases. These units typically consist of a pneumatic powered device that provides the positive pressure and connecting tubes, controls, adapters, sputum cups, and attachments (e.g., mouthpieces, masks) for intermittent deliver of gas to the patient. The oscillation frequency and pressure are usually in the range of 6 to 30 Hz and 10 to 20 cm of H20 respectively. Oscillatory intrapulmonary percussion units make no attempt to breathe for the patient, the oscillatory pressure is layered on top of the patient normal breathing. Most units include or may be connected to nebulizers and to oral or endotracheal suction equipment. They are intended to shear mucus from the airway wall by oscillatory forces, to aid in mucus mobilization and expectoration, for treatment of atelectasis, and frequently to deliver nebulized medications. | ||
| 20733 | AIRWAY CLEARANCE UNIT, POSITIVE EXPIRATORY PRESSURE | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Airway clearance units designed to generate positive airway pressure in the airways (typically 10 to 20 cm of H20 or larger) as the patient exhales through a resistance. Positive expiratory pressure (PEP) devices include one of a variety of fixed-orifice resistors that only generates pressure when the expiratory flow is high enough to generate back pressure from the orifice. PEP units typically include a soft, transparent, hand ventilation mask or mouthpiece, a T assembly with a one-way valve, and a manometer. The mask is applied tightly but comfortably over the mouth and nose. A mouthpiece can be also used, but only if the patient can maintain a reasonable seal and not release air through the nose during the procedure. PEP airway clearance units are mainly used to help remove pulmonary secretions. | ||
| 20734 | AIRWAY CLEARANCE UNIT, POSITIVE EXPIRATORY PRESSURE, OSCILLATORY | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Airway clearance units designed to apply forces at the airway opening to perform a simultaneous delivery of positive expiratory pressure and a high-frequency oscillation (HFO) of the air column in the conducting airways. These devices use one of several different techniques to create the airflow oscillation, including metallic ball vibrations and a combination of a counterweighted plug and a magnet. Oscillatory positive expiratory pressure units are used for prevention of early airway closure by stabilization of the airways with positive expiratory pressure (PEP) and to aid in mucus mobilization and expectoration in patients suffering from chronic obstructive pulmonary diseases. | ||
| 20735 | AIRWAY CLEARANCE UNIT, POSITIVE EXPIRATORY PRESSURE, OSCILLATORY, FLUTTER VALVE | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Handheld oscillatory positive expiratory pressure units consisting of a pipe-like device that includes a steel ball in the inner cone (i.e., the pipe bowl) that is loosely covered by a perforated cap. The weight of the ball provides positive airway pressure (close to 10cm of H20) during expiration (i.e., positive expiratory pressure, PEP), and the ball movement on/off the bowl generates oscillations with a changing frequency ranging from 2 to 30 Hz (typically about 15 Hz) according to the device position. Flutter valve devices are intended to shear mucus from the airway wall by oscillatory forces, prevention of early airway closure by stabilization of the airways with PEP, changes in mucus rheology, and to aid in mucus mobilization and expectoration. They are intended mainly for use in patients with chronic obstructive pulmonary diseases. | ||
| 20736 | AIRWAY CLEARANCE UNIT, POSITIVE EXPIRATORY PRESSURE, OSCILLATORY, MAGNETIC VALVE | 18863 | AIRWAY CLEARANCE UNITS | 6530 | PUL | 1 | Y | 8 | Y | 6 | 6 | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Handheld oscillatory positive expiratory pressure units consisting of a counterweighted lever and a magnet. The exhaled air passes through the cone which is intermittently occluded by a plug attached to the lever, producing airflow oscillations. A knob located at the distal end of the device adjusts the distance between the magnet and counterweighted plug, thereby adjusting the frequency, amplitude, and mean positive expiratory pressure (PEP). These units are available in two models, intended for patients with an expiratory flow capacity smaller or greater than 15 liter/minute respectively. Magnetic valve devices are intended to shear mucus from the airway wall by oscillatory forces, prevention of early airway closure by stabilization of the airways with PEP, and to aid in mucus mobilization and expectoration. They are intended for use in patients with chronic obstructive pulmonary diseases. | ||
| 27675 | ALARM SYSTEM, OCCUPANCY | 15550 | ALARMS | 6515 | NUR | 4 | L | 5 | Y | 12 | Alarm systems designed to activate audible and/or visual signals when patients attempt to move from a designated area such as a chair, wheelchair, bed, or room. These alarm systems are typically comprised of sensors deployed to determine the patient's location and connected to an electronic control unit. Occupancy alarm systems have several possible configurations and usually include one transmitter which can be used interchangeably with several sensors such as leg cuffs, floor mats, clothing clips, pressure pads and infrared motion detectors. Some occupancy alarm systems can also use two different sensors at the same time such as a bed pressure pad and an infrared motion detector. Some occupancy alarm systems can interface with nurse call systems providing remote alarms. Occupancy alarm systems are used to alert caregivers that a patient has or is attempting to move. Occupancy alarm systems can help reduce the likelihood of falls and can promote speedy assistance to patients who have already fallen by alerting caregivers that a patient who should not get up unassisted is doing so. | |||||||||
| 14351 | ALARM, ARTIFICIAL AIRWAY PRESSURE | 15550 | ALARMS | 6515 | ANE | 2 | Y | 7 | Y | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Alarms designed to activate audible (i.e., sound) and/or visual warnings when the gas pressure within the ventilation artificial airway of mechanically ventilated patients is outside a pre-established range. These devices typically include a pressure sensing line that is ideally attached to the breathing circuit at its junction with the endotracheal or tracheostomy tube, an electronic unit, and visual and/or sound alarms. Airway pressure alarms are mainly used with intensive and nonintensive care ventilators and/or anesthesia ventilators that do not include an airway pressure alarm as an integral component. Low pressure alarm may signal ventilator failure, breathing circuit disconnections, extubations, or leaks in the endotracheal tube; high-pressure alarms alert for conditions that can cause lung damage (i.e., barotraumas). | ||||
| 18596 | ALARM, CELLULAR TELEPHONE DETECTION | 15550 | ALARMS | 6515 | HF | 4 | L | 10 | N | 0.0 | 0.0 | Alarms designed to activate audible (i.e., sound) and/or visual signals when cellular telephones, walkie-talkies, or any other radio-frequency transmitters are operated in the vicinity (e.g., inside the same room) of electrical or magnetic medical devices vulnerable to radio-frequency signals (i.e., electromagnetic interference). These devices include the appropriate sensors to detect the radiated electromagnetic field, typically from 400 to 2,000 MHz), electronic circuitry, and sound and/or light sources as alarms. Cellular-telephone detection alarms are used to alert users and healthcare personnel of the operation of cell telephones inside a healthcare facility near vulnerable or potentially vulnerable medical devices (e.g., defibrillators, ventilators). | ||||||||
| 15824 | ALARM, CENTRAL GAS SYSTEM | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | N | $500.00 | $2,500.00 | Alarms designed to activate audible (i.e., sound) and/or visual alarms when a central gas system feature (e.g., line, outlet) is outside predetermined operating characteristics. These devices typically consist of an independent electronic unit, sensors, amplifiers, level controls, and visual displays and/or audible warnings that may be located at the site and/or in a central station. Dedicated area alarms for central gas systems are used to warn users of abnormal conditions such as pressure values and oxygen depletion. | ||||||||
| 26592 | ALARM, CENTRAL GAS SYSTEM, OXYGEN DEPLETION | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | N | Central gas system alarms designed to activate audible (i.e., sound) and/or visual alarms when the oxygen in the air supply line is below its normal (about 21%) atmospheric concentration (i.e., oxygen depletion). These devices typically consist of an independent electronic unit, sensors for continuous assessment of the pressure and/or concentration of oxygen, electronic circuits to amplify the signal, and visual displays and/or audible warnings that usually activate an alarm when the concentration of oxygen is in a range from 18% to 19%. Oxygen depletion alarms are usually activated by pressure loss (e.g., in central gas system oxygen lines and oxygen cylinder delivery lines). The alarms may be located at the site and/or in a central station. Dedicated oxygen depletion alarms are frequently included as an integral part of devices such as anesthesia machines and ventilators. | ||||||||||
| 26591 | ALARM, CENTRAL GAS SYSTEM, PRESSURE | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | N | Central gas system alarms designed to activate audible (i.e., sound) and/or visual alarms when the pressure (including partial vacuum level) of a central gas system line is outside (e.g., 20%) predetermined normal system pressure values. These devices typically consist of an independent electronic unit, pressure sensors, amplifiers, pressure level controls, and visual displays and/or audible warnings that may be located at the site and/or in a central station. Pressure alarms are used to warn users of abnormal conditions in the delivered gas pressures; alarms are also available for use at the central gas station to determine its status. | ||||||||||
| 26608 | ALARM, ENVIRONMENTAL EMERGENCY | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | N | Alarms designed to activate audible (i.e., sound) and/or visual warnings when a hazardous condition beyond a threshold level in a closed environment is detected. These alarms usually consist of a detector, appropriate transducers to generate an electrical signal, amplifiers, separate electric power systems and/or batteries, and sound and/or light sources that deliver signals (e.g., high-pitched sounds, intense flashing lights) to warn people that the hazardous condition is present. Alarms intended to be fixed in a particular room providing only emergency signals locally and alarm systems intended for a complete facility that may also include remote alarms (e.g., police and/or fire stations) are available. Environmental emergency alarms are used in healthcare facilities for detecting a variety of hazardous conditions, including fire, smoke, carbon monoxide, explosive and toxic gases. Alarms intended to be fixed in a particular room providing only emergency signals locally and alarm systems intended for a complete facility that may also include remote alarms (e.g., police and/or fire stations) are available. Dedicated alarms intended for fire and/or smoke, carbon monoxide, and other hazardous conditions are also available. Emergency alarms may be used also to activate safety (e.g., unlock doors) and/or protection (e.g., sprinklers) mechanisms. | ||||||||||
| 26613 | ALARM, ENVIRONMENTAL EMERGENCY, CARBON MONOXIDE | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | N | Environmental emergency alarms designed to activate audible (i.e., sound) and/or visual warnings when carbon monoxide (CO) beyond a threshold level in a closed environment is detected. These alarms usually consist of a CO detector (e.g., tin oxide), appropriate transducers to generate an electrical signal, amplifiers, separate electric power systems and/or batteries, and sound and/or light sources that deliver signals (e.g., high-pitched sounds, intense flashing lights) to warn people that high CO levels are present. CO alarms intended to be fixed in a particular room providing only emergency signals locally and alarm systems intended for a complete facility that may also include remote alarms (e.g., police and/or fire stations) are available. CO alarms are usually required in facilities that use fuel-burning appliances such as furnaces, ranges, water and room heaters, motor-powered equipment such as portable generators, and/or fireplaces, and other charcoal-burning devices used in homes and other enclosed areas. | ||||||||||
| 25099 | ALARM, ENVIRONMENTAL EMERGENCY, FIRE/SMOKE | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | N | Environmental emergency alarms designed to activate audible (i.e., sound) and/or visual warnings when smoke beyond a threshold level and/or fire in a closed environment are detected. These alarms usually consist of a heat and/or smoke detector, appropriate transducers to generate an electrical signal, amplifiers, separate electric power systems and/or batteries, and sound and/or light sources that deliver signals (e.g., high-pitched sounds, intense flashing lights) to warn people that a fire is present. Fire/smoke alarms intended to be fixed in a particular room providing only emergency signals locally and alarm systems intended for a complete facility that may also include remote alarms (e.g., police and/or fire stations) are available. They may be used also to activate safety (e.g., unlock doors) and/or protection (e.g., sprinklers) mechanisms. | ||||||||||
| 26614 | ALARM, ENVIRONMENTAL EMERGENCY, OXYGEN DEPLETION | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | N | Environmental emergency alarms designed to activate audible (i.e., sound) and/or visual warnings when oxygen concentration in a closed environment is below its normal (about 21%) atmospheric value (i.e., oxygen depletion). These devices typically consist of a sensor for continuous assessment of oxygen concentration, electronic circuits to amplify the signal, and visual displays and/or audible warnings that usually initiate an alarm when the concentration of oxygen is between 18% and 19%. Oxygen depletion environmental emergency alarms are intended mainly for use in closed rooms where other gases are manipulated, such as clinical laboratories that perform procedures involving carbon dioxide and/or liquid nitrogen for cryopreservation. Alarms intended to be fixed in a particular room providing only emergency signals locally and alarm systems intended for a complete facility that may also include remote alarms (e.g., police and/or fire stations) are available. These alarms are usually fixed permanently on the walls. | ||||||||||
| 26601 | ALARM, EQUIPMENT TEMPERATURE | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | Y | 6 | 12 | Alarms designed to activate audible (i.e., sound) and/or visual warnings when the temperature inside the equipment becomes outside pre-established limits. These alarms typically include an electronic unit for data processing, temperature sensors, and visual (e.g., displays) and/or audible warnings that may be located at the site of the equipment and/or at a central station. Equipment temperature alarm systems are used in clinical laboratory devices (e.g., refrigerators, incubators, water baths), pharmacy equipment (e.g., freezers), and other healthcare facility equipment. | ||||||||
| 26602 | ALARM, EQUIPMENT TEMPERATURE, REFRIGERATOR/FREEZER | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | Y | 6 | 12 | Temperature alarms designed to activate audible (i.e., sound) and/or visual warnings when the temperature inside a refrigerator or freezer intended for clinical use becomes outside pre-established limits. These alarms typically consist of an electronic unit (frequently battery operated) with temperature measurement controls that can be fixed in a wide range of temperatures (e.g., from -80 to 125 degrees C, or -112 to 257 degrees F), temperature sensors, and visual (e.g., displays) and/or audible warnings that may be located at the site of the equipment and/or less frequently at a central station; the alarms are suitable for working inside freezers and refrigerators. Refrigerator/freezer temperature alarms are used in places such as clinical laboratories, pharmacies, and blood banks to facilitate the control of refrigerated and/or frozen temperature-sensitive samples and/or supplies (e.g., blood samples, biological products). | ||||||||
| 23475 | ALARM, FOOT LOAD | 15550 | ALARMS | 6515 | HF | 3 | L | 10 | N | |||||||||||
| 20351 | ALARM, GRAVITY INFUSION | 15550 | ALARMS | 6515 | NUR | 2 | Y | 10 | Y | 6 | 12 | 12 | 12 | 0.0 | 0.0 | Alarms designed to activate a visual or more frequently audible (i.e., sound) signal when a fluid container used for gravity infusions is nearly empty. These alarms typically consist of a portable battery-operated electronic unit with an attached arm that senses the weight of the fluid bag, operating visual (e.g., LED ) and/or sound alarms when pre-established minimum weights (e.g., 150 g) are reached. The units typically include a clamp for attachment to any vertical intravenous hanger. Gravity infusion alarms can also be used to indicate the completion of bolus infusions and to help in the prevention of air introduction into the infusion line. | ||||
| 12585 | ALARM, OCCUPANCY, BED | 15550 | ALARMS | 6515 | NUR | 4 | L | 5 | Y | 12 | 12 | 0.0 | 0.0 | Occupancy alarms designed to activate audible and/or visual signals when unattended patients attempt to get out of bed. These alarms typically consist of pressure pad sensors placed underneath or on top of the mattress. These alarms are deployed to determine the patient's location and are connected to an electronic control unit; some bed occupancy alarms can interface with nurse call systems providing remote alarms. Bed occupancy alarms are used to alert caregivers that a patient has or is attempting to move. Bed occupancy alarms can help reduce the likelihood of falls and can promote speedy assistance to patients who have already fallen by alerting caregivers that a patient who should not get out of bed unassisted is doing so. | ||||||
| 17531 | ALARM, OCCUPANCY, CHAIR/WHEELCHAIR | 15550 | ALARMS | 6515 | NUR | 4 | L | 10 | Y | 12 | 12 | 0.0 | 0.0 | Occupancy alarms designed to activate audible and/or visual signals when patients attempt to get out of their chairs or wheelchairs. These alarms typically consist of pressure pad sensors placed on top of or beneath the seat of a chair or wheelchair. These alarms are deployed to determine the patient's location and are connected to an electronic control unit; some chair/wheelchair occupancy alarms can interface with nurse call systems providing remote alarms. Chair/wheelchair occupancy alarms are used to alert caregivers that a patient has or is attempting to move. Chair/wheelchair occupancy alarms can help reduce the likelihood of falls and can promote speedy assistance to patients who have already fallen by alerting caregivers that patients who should not get out of their chairs unassisted are doing so. | ||||||
| 22860 | ALARM, PHYSIOLOGIC MONITORING SYSTEM, REMOTE | 15550 | ALARMS | 6515 | NUR | 4 | Y | 5 | Y | 12 | 12 | 0.0 | 0.0 | Physiologic monitoring system alarms designed to generate remote audible and/or visual signals on auxiliary devices sited away from the central station and/or patient room, when patient status triggers an alarm. These systems may include electronic display screens and/or audio devices (e.g., loudspeakers); the devices may also provide additional information such the reason for the alarm and/or the room number of the patient whose status triggered the alarm. Physiologic monitoring system alarms are placed in hallways and/or multipatient rooms, providing healthcare staff ready access to patient alarm information. Some alarms may be available as components of physiologic monitoring systems, facilatating installation and support. Physiologic system auxiliary displays intended to show the monitored data (i.e., numeric, waveforms) as well as the alarm signals are also available. | ||||||
| 23477 | ALGESIMETER, CUTANEOUS, THERMAL STIMULUS | 23477 | ALGESIMETERS, CUTANEOUS, THERMAL STIMULUS | 6515 | DRM | 4 | L | 10 | N | |||||||||||
| 16351 | ALGINATE MIXING SYSTEM | 16351 | ALGINATE MIXING SYSTEMS | 6520 | DEN | 4 | L | 10 | N | 0.0 | 0.0 | Mixers designed to blend a salt of alginic acid (i.e., alginate) with water (and appropriate additives if necessary) to produce a dental impression material that sets rapidly and irreversibly. These devices typically consist of an electrical mixer with a well, a container (e.g., cup) used to mix the alginate with water before placing in the mixer well, and external controls to operate the mixer. Alginate mixers are used to obtain smooth and uniform mixtures of dental impression materials in situ at the dentist office. | ||||||||
| 10082 | AMALGAMATOR | 10082 | AMALGAMATORS | 6520 | DEN | 4 | L | 7 | Y | 12 | 12 | 0.0 | 0.0 | Devices, usually electrically powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles. The capsule may be an integral part of the amalgamator or a separate component placed into the amalgamator. | ||||||
| 17536 | AMBLYOSCOPE | 17536 | AMBLYOSCOPES | 6540 | OPH | 3 | L | 10 | Y | 12 | 12 | 0.0 | 0.0 | Reflecting stereoscopes that present to the two eyes two separate target images through two angled tubes. The angle between the two tubes can be adjusted horizontally and vertically. Therefore, convergence and divergence can be measured, binocular vision can be measured or trained, and vision can be stimulated in the amblyopic eye. | ||||||
| 17162 | AMBULANCE, AIR TRANSPORT | 10085 | AMBULANCES | 2320 | HF | 4 | Y | 15 | N | 0.0 | 0.0 | Aircraft (e.g., helicopters, airplanes), designed for transporting the sick or wounded, that are equipped with the necessary devices and supplies to maintain or improve the clinical status of the patient during transport. | ||||||||
| 17171 | AMBULANCE, GROUND TRANSPORT | 10085 | AMBULANCES | 2320 | HF | 4 | Y | 10 | N | $25,000.00 | $100,000.00 | Motor vehicles designed and equipped to transport and stabilize the sick or wounded. | ||||||||
| 27036 | AMMETER | 27036 | AMMETERS | 6625 | ENG | 4 | L | 8 | Y | 12 | 12 | 12 | 12 | Measuring instruments designed to measure the flow of electric current (either direct or alternating, DC or AC respectively, or both) along a conductor of an electric or electronic circuit, usually expressed in amperes. These instruments typically consist of electromechanical (analog) or more frequently electronic (usually digital) instruments with appropriate leads. Practical instruments can perform the most common current measurements needed for electric and electronic equipment, circuits, and components. Ammeters are mainly used in healthcare facilities in inspection, preventive maintenance, repair, and calibration of medical devices and other hospital equipment. | ||||||
| 10088 | AMNIOSCOPE | 10088 | AMNIOSCOPES | 6515 | SUR | 3 | Y | 10 | Y | 12 | 12 | 0.0 | 0.0 | Endoscopes designed for direct insertion through the cervical canal into the closed sac between the embryo and the membrane involving it (i.e., the amniotic cavity) for visual examination, biopsy, and/or treatment of the fetus before the membrane is broken. Amnioscopes usually consist of an outer sheath, a lighting system, and a working channel for catheters and operative devices; these endoscopes may be rigid or flexible. | ||||||
| C0251 | AMPLIFIER, OTHER | C0251 | AMPLIFIERS, OTHER | 6515 | NUR | 4 | L | 8 | N | 0.0 | 0.0 | |||||||||
| 17140 | ANALGESIA UNIT, CRYOGENIC | 15014 | ANALGESIA UNITS | 6515 | ANE | 2 | Y | 6 | Y | 6 | 12 | 12 | 12 | $8,250.00 | $25,000.00 | Analgesia units that alleviate pain by freezing body tissues. These units consist of a cryostat and a cooling probe; most units also include a peripheral nerve block stimulator (nerve locator). A compressed gas (e.g., carbon dioxide, nitrous dioxide) is circulated through the probe, allowing expansion near the tip; frequently, some free-thaw cycles are performed. Cryogenic analgesia application results in reversible, though prolonged (weeks or even months) peripheral nerve block; it is used for postoperative and chronic intractable pain relief. | ||||
| 16953 | ANALGESIA UNIT, INHALATION | 15014 | ANALGESIA UNITS | 6515 | ANE | 2 | Y | 6 | Y | 6 | 6 | 12 | 12 | 0.0 | 0.0 | Analgesia units that alleviate pain through patient inhalation of a gas or mixture of gases. These units typically consist of a device that mixes nitrous oxide and oxygen from two gas cylinders in a previously selected proportion and delivers it to the patient using appropriate inhalers; the mixture must have not less than 20% to 30% oxygen content. Inhalation analgesia units help patients retain consciousness while pain sensations are subdued; they are mostly used in dentistry, but they have also been used for women in labor, in emergency care, and for minor surgery. | ||||
| C0344 | ANALYZER, AUDIOMETER | C0344 | ANALYZERS, AUDIOMETER | 6625 | ENG | 4 | Y | 8 | Y | 12 | 12 | 12 | 12 | |||||||
| C0345 | ANALYZER, ELECTRICAL SAFETY | C0345 | ANALYZERS, ELECTRICAL SAFETY | 6625 | ENG | 4 | Y | 8 | Y | 12 | 12 | 12 | 12 | |||||||
| 18959 | ANALYZER, ENVIRONMENTAL/GAS SYSTEM | 18959 | ANALYZERS, ENVIRONMENTAL/GAS SYSTEM | 6665 | PM | 3 | L | 8 | Y | 12 | 12 | 12 | 12 | 12 | 12 | $950.00 | $15,000.00 | Analyzers designed to take samples and measure and display the concentration of one or more gases (e.g., oxygen, carbon monoxide, nitrogen dioxide, ethylene oxide, halogenated anesthetics) in a gas mixture. These analyzers typically consist of portable units operated either by line power or batteries; they include gas sensors (e.g., optical, electrochemical, infrared), a built-in sampling pump, electronic circuitry, and a display. These units may also include recording capabilities. Environmental/gas system analyzers are used to measure the concentration of gases in healthcare facility environments (e.g., operating rooms, intensive care units, laboratories), at a sampling point of a compressed medical air or gas system, and/or in other medical devices used for respiratory therapy or anesthesia. | ||
| 23674 | ANALYZER, ENVIRONMENTAL/GAS SYSTEM, CARBON DIOXIDE | 18959 | ANALYZERS, ENVIRONMENTAL/GAS SYSTEM | 6665 | PM | 3 | L | 8 | Y | 12 | 12 | 12 | 12 | Environmental/gas system analyzers designed to measure and display the concentration of carbon dioxide (CO2) in a sample of gas. These analyzers are typically portable units based in photometric technologies (e.g., using dual wavelength infrared sensors). CO2 environmental/gas system analyzers are used to determine CO2 concentrations in closed (e.g., clinical laboratories, laboratory incubators) and/or open air (atmospheric) conditions; they can usually measure in a range from 0% to 100%, but devices intended only for accurate measuring of very small concentrations (e.g., from a few to several thousand ppm) are also available. Some devices include pressure and/or temperature compensation and allow remote measurement. | ||||||
| 11941 | ANALYZER, ENVIRONMENTAL/GAS SYSTEM, HALOGENATED ANESTHETIC | 18959 | ANALYZERS, ENVIRONMENTAL/GAS SYSTEM | 6665 | PM | 4 | L | 8 | Y | 12 | 12 | 12 | 12 | $2,550.00 | $3,550.00 | Environmental/gas system analyzers designed to measure and display the concentration of halogenated compounds used for anesthesia; some analyzers can also measure nitrous oxide concentration. These analyzers are typically portable units based either on an optical interference photometer (i.e., interferometer) or on an infrared spectrophotometer. Halogenated anesthetic analyzers are mostly used to check anesthesia unit vaporizer accuracy usually at the gas outlet during inspection procedures; they are also used to check leaks in anesthesia systems, or in the environment, especially at sites where accumulated gases would affect personnel (e.g., anesthesiologists). | ||||
| 23713 | ANALYZER, ENVIRONMENTAL/GAS SYSTEM, OXYGEN | 18959 | ANALYZERS, ENVIRONMENTAL/GAS SYSTEM | 6665 | PM | 3 | L | 8 | Y | 12 | 12 | 12 | 12 | Environmental/gas system analyzers designed to measure and display the concentration of oxygen in a sample of gas. These analyzers are typically portable units based in one of several technologies, including the use of the paramagnetic properties of oxygen and in the creation of zirconia oxygen electrolytic cells. Oxygen environmental/gas system analyzers are used to determine oxygen concentrations in closed and/or open air conditions, frequently in contaminated atmospheres; they can usually measure in a range from 0% to 100%, but devices intended only for accurate measuring of very small concentrations of oxygen are also available. | ||||||
| C0252 | ANALYZER, HYDROGEN SULFIDE | 18959 | ANALYZERS, ENVIRONMENTAL/GAS SYSTEM | 6665 | PM | 3 | L | 8 | Y | 12 | 12 | 12 | 12 | 0.0 | 0.0 | |||||
| 18617 | ANALYZER, LABORATORY, BLOOD GAS | 18614 | ANALYZERS, LABORATORY, BLOOD | 6630 | LAB | 3 | Y | 8 | Y | 12 | 12 | 12 | 12 | 12 | 12 | 12 | $12,000.00 | $50,000.00 | Laboratory analyzers that measure concentrations of gases in samples of plasma, serum, or whole blood. These analyzers are used for measuring partial pressure of carbon dioxide (PCO2) and oxygen (PO2), usually in arterial whole blood specimens, using two different sets of electrodes. Some laboratory blood gas analyzers also calculate other parameters, such as oxygen total content (ctO2) and bicarbonate (HCO3-). They may also perform electrolyte and/or hematologic determinations (e.g., hematocrit). Blood gas analyzers are used to determine oxygen/carbon dioxide exchange in patient diagnosis and regulation of therapy. | |
| 15709 | ANALYZER, LABORATORY, BLOOD GAS/PH | 18614 | ANALYZERS, LABORATORY, BLOOD | 6630 | LAB | 3 | Y | 7 | Y | 12 | 12 | 12 | 12 | 12 | 12 | $17,000.00 | $54,000.00 | Laboratory blood gas analyzers used to directly measure pH and partial pressure of carbon dioxide (PCO2) and oxygen (PO2), usually in arterial whole blood specimens. Measurements are made using three different sets of electrodes. Some laboratory blood gas/pH analyzers calculate other parameters, such as oxygen total content and bicarbonate HCO3, and also perform electrolyte and/or hematologic determinations (e.g., hematocrit). These analyzers are used to determine a patient's acid/base balance and oxygen/carbon dioxide exchange for diagnosis and regulation of therapy. | ||
| 18618 | ANALYZER, LABORATORY, BLOOD GAS/PH/ELECTROLYTE | 18614 | ANALYZERS, LABORATORY, BLOOD | 6630 | LAB | 3 | Y | 8 | Y | 12 | 12 | 12 | 12 | 12 | 12 | 12 | $29,000.00 | $32,000.00 | Laboratory blood gas analyzers which combine the capacities of both the blood gas/pH analyzers and the electrolyte analyzers used in the laboratory. These analyzers can directly measure pH and partial pressure of carbon dioxide (PCO2) and Oxygen (PO2), as well as the most common ions (i.e., sodium [Na+], potassium [K+], chloride [Cl-], bicarbonate [HCO3-] ) present in whole blood. These analyzers are used to determine a patient's acid-base balance and oxygen/carbon dioxide exchange and also to assess abnormal electrolyte levels in the blood. | |
| 18619 | ANALYZER, LABORATORY, BLOOD GAS/PH/ELECTROLYTE/METABOLITE | 18614 | ANALYZERS, LABORATORY, BLOOD | 6630 | LAB | 3 | Y | 8 | Y | 12 | 12 | 12 | 12 | 12 | 12 | 12 | $29,000.00 | $32,000.00 | Laboratory blood gas analyzers designed to be used to assess some metabolites in addition to measuring concentrations of blood gas, pH, and electrolytes. These analyzers can directly measure pH and partial pressure of carbon dioxide (PCO2) and oxygen (PO2), the most common ions (i.e. sodium [Na+], potassium [K+], chloride [Cl-], bicarbonate [HCO3-]), and some metabolites such as calcium, magnesium, glucose, and lactate present in whole blood. | |
| 18615 | ANALYZER, LABORATORY, BLOOD, BILIRUBIN | 18614 | ANALYZERS, LABORATORY, BLOOD | 6630 | LAB | 3 | Y | 8 | Y | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 0.0 | 0.0 | Laboratory blood analyzers that measure the concentration of bilirubin in serum, plasma, and/or whole blood. Most of these analyzers use spectrophotometric methods for measurements. Some of them can measure total bilirubin and direct (water-insoluble) bilirubin. For neonates, direct spectrophotometric determinations can be made because normal pigments have not begun to accumulate; in other patients it is needed to add appropriate reagents to the samples before and during the test. These analyzers are used to determine pathologic or physiologic high bilirubin levels in neonates and measure bilirubin concentration in children and adults to assess hepatic metabolic disorders. | |
| 17109 | ANALYZER, LABORATORY, BLOOD, GLYCATED HEMOGLOBIN | 18614 | ANALYZERS, LABORATORY, BLOOD | 6630 | LAB | 3 | Y | 7 | Y | 12 | 12 | 12 | 12 | 12 | 12 | $57,000.00 | $77,000.00 | Laboratory blood analyzers dedicated to measuring levels of glycohemoglobin (i.e., glycated hemoglobin, also known as glycosylated and glucosylated hemoglobin) in blood. These analyzers typically use a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high-pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography, immunoassay). |
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