Attachment 2-Proposal Template Syringe and Needle-FINAL-1530.xlsx
XLSX spreadsheet 18 KB Posted
- Attached to
- Needles and Syringes Federal contract opportunity
- Solicitation number
- W911SR-20-R-0003
About this file
This solicitation requests proposals for the urgent purchase of FDA-approved combination needle and syringe units or individual needles and syringes. The Department of Health and Human Services seeks to acquire 500 million units within one year to support the COVID-19 response, with as many as possible by December 31, 2020. Offerors must propose a minimum of five million units by the earlier date to be considered. Awards will be made to the lowest priced technically acceptable proposals for either sterile combination units or sterile syringes and needles packaged individually at a one-to-one ratio. Competition will evaluate 270 million one milliliter syringes with specified needles and 230 million three milliliter syringes with specified needles. The Army Contracting Command will make multiple awards as needed to meet the overall quantity up to the ceiling of 500 million units.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| B08-Combined Synopsis-Solicitation_Syringe and Needle-COVID-Final -Amendment 3.docx | DOCX document | |
| Attachment 4-Pricing Template Syringe and Needle for COVID-19-AMENDMENT 2.xlsx | XLSX spreadsheet | |
| W911SR-20-R-0003 Industry Question Matrix Round 2-AMENDMENT 2.xlsx | XLSX spreadsheet | |
| Attachment 1-Statement of Work_COVID Needles and Syringes-Final-Amendment 1.docx | DOCX document | |
| W911SR-20-R-0003 Industry Question Matrix 28 May 2020.xlsx | XLSX spreadsheet | |
| Combined Synopsis-Solicitation_Syringe and Needle-COVID-Final -Amendment 1.docx | DOCX document | |
| Attachment 1-Statement of Work_COVID Needles and Syringes-Final-1500.docx | DOCX document | |
| Combined Synopsis-Solicitation_Syringe and Needle-COVID-Final -1500.docx | DOCX document | |
| Attachment 4-Pricing Template Syringe and Needle for COVID-19-Final-1500....xlsx | XLSX spreadsheet | |
| Attachment 3_CDRL_Syringe and Needle Final-1500.pdf |
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Text version
OVERVIEW-SYRINGE &SAFETY
INTEGRATED SYRINGE AND NEEDLE UNITS
FOR COVID-19 NATIONAL EMERGENCY RESPONSE
The Syringe and Needle Units shall include the following components: (1) individually wrapped sterile syringes with individually wrapped sterile needles, (2) sterile needle/syringe combination unit, or (3) a mixture of combinations units and individually wrapped syringes with equal number of individually wrapped sterile needles.
The Offeror shall identify the country of origin, as specified in the subsequent Tabs in this document.
The hypodermic syringes shall be FDA cleared for the use to inject medicines and vaccines into, or withdraw fluids from, the body. The Offeror shall provide their preauthorization from the FDA, 510(k) approval for the proposed syringe and needle.
| Labeling: The Needles and Syringes Units shall be labeled in accordance with 21 CFR Part 801 as it relates to intended use. |
| Shipping and packaging shall be in accordance with Title 21 Code of Federal Regulations (CFR), Subpart K. |
Ship to:
SHIP TO DODAAC:
STORAGE RIC:
OWNER RIC:
Dispensing Syringe
DISPENSING SYRINGE
CRITERIA OFFEROR Name Here / Response Below
| Description: Dispensing syringe shall allow for the controlled and precise flow of liquid. They are used to inject medications or other liquids into body tissues. Manual syringes shall consist of a barrel, stopper, and plunger. |
| Specifications: Dispensing syringes shall comply with the following: |
| 21 Code of Federal Regulations (CFR) 880.5860 and Internaltional Standards Organization (ISO) 7886-1:2017, and Current Good Manufacturing Practice (cGMP) |
| a. The device shall be intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. |
| b. Heavy duty barrel. The barrel shall have a scale showing the capacity of the syringe. |
| c. Stopper. The stopper shall maintain the fluid in the barrel between the syringe nozzle and the Plunger. |
| d. Plunger. The plunger shall aspirate and inject fluids into and out of the syringe |
| e. Disposable |
| f. Luer lock to accept luer hub applicator (e.g. needle) |
| g. Acceptable sizes are 1mL and 3mL |
| h. Sterile individually wrapped packaging |
| 510(k) Approval Letters |
| PERFORMANCE SPECIFICATIONS: |
| Class II Performance Standards: The Offeror shall: |
| (1) Utilize FDA-approved dispensing syringes |
| (2) Individually wrap and sterilize each syringe prior to shipment |
COMBINATION NEEDLE (SAFETY NEEDLE) AND SYRINGE UNIT:
syringe coupled with needle for safety shall be acceptable as long as the components comply with all of the specifications above, except for the needle and syringe are packaged together.
| Syringe: Sizes acceptable are 1ml or 3ml |
| Needle: 23 Gauge, Length 1," or 1.5" and/or 25 Gauge, Length 1" |
| 510(k) Approval Letters |
| Country of Origin |
Hypodermic Needle
HYPODERMIC NEEDLE
CRITERIA OFFEROR Name Here / Response Below
| Description: Hypodermic needles are slender, hollow instruments for introducing material into the body parenterally |
| Specifications: The Hypodermic Needle shall comply with the following: |
| 21 Code of Federal Regulations (CFR) 880.5570, International Standards Organization (ISO) 7864, single use hypodermic needles, Current Good Manufacturing Practice (cGMP) |
| a. Shall be a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (Luer hub) designed to mate with a male connector (Luer lock nozzle) of a piston syringe or intravascular administration set. |
| b. Disposable |
| c. Luer hub to attach to luer lock |
| d. Acceptable 23 Gauge, Length 1," or 1.5", and/or 25 Gauge, Length 1" |
| e. Sterile individually wrapped packaging |
| f. Safety-engineered |
| 510(k) Approval Letters |
| Country of Origin |
| PERFORMANCE SPECIFICATIONS: |
| Class II Performance Standards: The Offeror shall: |
| (1) Utilize FDA-approved needles |
| (2) Individually wrap and sterilize each needle prior to shipment |
COMBINATION NEEDLE (SAFETY NEEDLE) AND SYRINGE UNIT:
Hypodermic syringe coupled with integrated needle for safety shall be acceptable as long as the components comply with all of the specifications above, except for the needle and syringe are packaged together
| Needle: 23 Gauge, Length 1," or 1.5" and/or 25 Gauge, Length 1" |
| Syringe: Sizes acceptable are 1ml or 3ml |
| 510(k) Approval Letters |
| Country of Origin |
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