RFI - heated high_flow respiratory support systems.pdf

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6515--Respiratory Support Devices - CIVAHCS
Solicitation number
36C26326Q0714
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This is a Request for Information (RFI) issued by VISN 23 (Veterans Health Administration) for heated high-flow respiratory support systems equivalent to the Fisher & Paykel Airvo 3. The RFI is for market research purposes only and does not constitute a solicitation or binding contract. VISN 23 seeks to identify potential vendors capable of providing this medical device equipment and is requesting responses from interested companies by contacting Joshua Imdacha, Contracting Officer, at Joshua.Imdacha@va.gov.

The device must deliver heated and humidified high-flow therapy up to at least 70 L/min with an integrated flow generator, adjustable temperature settings (approximately 31°C–37°C), integrated oxygen blending up to 100% FiO₂ with ±3% accuracy, and compatibility with Optiflow+ patient interfaces. Additional requirements include real-time monitoring displays, audible and visual alarms, FDA clearance for high-flow oxygen therapy, compliance with IEC 60601-1-8 medical device alarm standards, certification for inpatient hospital use, compatibility with VA-approved disinfectants, and operation on standard hospital AC power (100–240 V). The device must support pole-mounted operation and include one humidification chamber, Airvo-compatible breathing circuits, one adult Optiflow+ nasal cannula starter set, and manufacturer-required accessories. Vendors must provide company name, point of contact, phone number, email address, product information, DUNS number, and business size. Critically, all responses must include the place of manufacture for the equipment, as the Buy American Act applies to this requirement; responses lacking this information will not be considered. The applicable NAICS code is 339112.

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REQUEST FOR INFORMATION

VISN 23 is requesting information for companies who offer the following goods or equivalent.

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY: The market research is looking to identify potential vendors who have the capabilities to offer the following: Heated high‑flow respiratory support systems brand name or equal to Fisher & Paykel Airvo 3

A. Description & Salient Characteristics:

The device must:

• Provide heated and humidified high‑flow therapy up to at least 70 L/min

• Integrated flow generator (no external compressor required)

• Adjustable temperature settings within clinically valid ranges (including a typical range of approximately 31°C–37°C)

• Integrated oxygen blending up to 100% FiO₂

• FiO₂ blending accuracy within clinically acceptable tolerances (approximately ±3% or better)

• Compatible with Optiflow+ patient interfaces

• Real‑time monitoring display (temperature, flow, FiO₂)

• Approved disinfection/sterilization compatibility

• Audible and visual alarms (disconnection, temperature, flow, system faults)

• Quiet operation suitable for patient care areas

• Capable of continuous operation

• FDA‑cleared for high‑flow oxygen therapy

• Alarm system performance compliant with applicable medical device alarm standards (e.g., IEC

60601‑1‑8)

• Certified for inpatient hospital use

• Exterior surfaces compatible with VA‑approved disinfectants

• Minimum 1‑year warranty (parts and labor)

• Minimal annual maintenance

• Manufacturer technical support included

• Must operate on standard hospital AC power (100–240 V) with a medical‑grade power supply

• Must support pole‑mounted operation suitable for movement within inpatient environments

• The accessories included must be:

o One humidification chamber per unit o Airvo‑compatible breathing circuits o One adult Optiflow+ nasal cannula starter set per unit o Compatibility with standard wall oxygen o All manufacturer‑required tubing, cables, power supplies included o Breathing circuits must be single‑patient‑use and compatible with VA infection‑control protocols

The Buy American Act applies to this requirement. In your responses you must include the place of manufacture for the above items or equal items that can satisfy this requirement.

NAICS: 339112

If your company sells the Equipment listed above, please contact me at Joshua.Imdacha@va.gov and provide the following information and any additional information that you deem pertinent:

Company Name

POC Phone Number

Email Address

Product(s) Duns Business Size

BUY AMERICAN ACT

The Buy American Act applies to this requirement. In your responses you must include the place of manufacture for the above items or equal items that can satisfy this requirement. Responses to this notice that do not contain this required info will not be considered.

DISCLAIMER

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

Thank you, Joshua Imdacha Contracting Officer mailto:Joshua.Imdacha@va.gov

DISCLAIMER

File details come from the government source that posted it. Updated .