Implantable Medical-Grade Primary Lithium Batteries
Closed Solicitation Posted
- Solicitation number
- 75F40126Q00420
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 335910 Battery Manufacturing
- PSC
- 6135 Batteries, Nonrechargeable
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration Office of Acquisition and Grant Services seeks procurement of twenty implantable medical-grade primary lithium batteries of Li/SVO-CFx chemistry in two configurations, with proposals due September 15, 2026 and questions due September 10, 2026 at 12:00 PM ET. This is a one-time purchase with no set-aside.
Place of performance is FDA Building 62, Room 1216, Silver Spring, Maryland 20993, with FOB Destination. Item 1 comprises ten units in high-rate configuration: rated capacity 1.70–1.90 Ah (nominal 1.78 Ah), open circuit voltage 3.15–3.40 V (nominal 3.25 V), capable of pulse discharge with continuous background load 95.3 kO, pulse amplitude 3.0 A, pulse duration 10 seconds, and pulse frequency up to once every 150 days at 2.0 V cutoff. Item 1 requires stainless steel case, negative case polarity, molybdenum or equivalent terminal, hermetic seal, 17 g weight, 6.5 cc volume, approximate dimensions 34.93 × 27.94 × 6.30 mm (not to exceed by more than 5%), and storage temperature −20°C to +60°C. Item 2 comprises ten units in medium-rate configuration: rated capacity 4.80–5.00 Ah (nominal 4.92 Ah), open circuit voltage 3.15–3.40 V (nominal 3.25 V), capable of medium-rate sustained discharge with background load 9.53 kO, pulse amplitude 20 mA, pulse duration 900 seconds, and pulse frequency up to once every 63 days at 2.0 V minimum cutoff. Item 2 requires titanium case, negative case polarity, titanium or equivalent terminal, hermetic seal, 22 g weight, 12.5 cc volume, approximate dimensions 46.48 × 31.70 × 9.63 mm (not to exceed by more than 5%), operating temperature 37°C nominal, and storage temperature −20°C to +60°C. All units must be new, unused, from the same manufacturing lot per configuration, and have a minimum of two years remaining shelf life from manufacture date at delivery. Item 2 delivery is due within 30 calendar days after award; Item 1 delivery is due within 180 calendar days after award, with firm deadline March 31, 2028. No manufacturer, brand, model, or part number is specified; any product meeting all stated salient characteristics is acceptable. Award is made on a Lowest Price Technically Acceptable basis, with technical acceptability determined pass/fail against stated salient characteristics. The NAICS code is 335910 (Battery Manufacturing); PSC is 6135 (Batteries, Nonrechargeable). Offerors must submit technical and price quotations, warranty terms, UEI and SAM.gov registration confirmation, lead times, country of origin documentation, and product literature demonstrating compliance. The Government accepts the contractor's standard commercial warranty and quality assurance system. The contractor must replace any damaged, defective, or nonconforming items at no cost within 30 calendar days of notification.
Notice text
Implantable Medical-Grade Primary Lithium Batteries — The contractor shall furnish twenty (20) new and unused implantable medical-grade primary lithium batteries of Li/SVO-CFx chemistry, in two configurations of ten (10) units each. No manufacturer, brand, model, or manufacturer part number is specified. Any product meeting every stated salient characteristic is acceptable.
Item 1 — High-rate configuration (Qty 10 EA): Rated capacity 1.70 Ah minimum to 1.90 Ah maximum (nominal 1.78 Ah); OCV-BOL 3.15 V minimum to 3.40 V maximum (nominal 3.25 V); capable of pulse discharge with continuous background load ≥95.3 kΩ, pulse amplitude ≥3.0 A, pulse duration 10 seconds, pulse frequency up to once every 150 days, and 2.0 V cutoff. Stainless steel case; negative case polarity; molybdenum or equivalent terminal; hermetically sealed; weight ≤17 g; volume ≤6.5 cc; approximate dimensions 34.93 mm × 27.94 mm × 6.30 mm and shall not exceed these values by more than 5%; storage temperature –20°C to +60°C. All 10 units shall be from the same manufacturing lot.
Item 2 — Medium-rate configuration (Qty 10 EA): Rated capacity 4.80 Ah minimum to 5.00 Ah maximum (nominal 4.92 Ah); OCV-BOL 3.15 V minimum to 3.40 V maximum (nominal 3.25 V); capable of medium-rate sustained discharge with pulsing, background load 9.53 kΩ, pulse amplitude 20 mA, pulse duration 900 seconds, pulse frequency up to once every 63 days, cutoff voltage 2.0 V minimum, with usable capacity 4.80 Ah to 5.00 Ah between OCV-BOL and cutoff at 37°C. Titanium case; negative case polarity; titanium or equivalent terminal; hermetically sealed; weight ≤22 g; volume ≤12.5 cc; approximate dimensions 46.48 mm × 31.70 mm × 9.63 mm and shall not exceed these values by more than 5%; operating temperature 37°C nominal; storage temperature –20°C to +60°C. All 10 units shall be from the same manufacturing lot.
For both configurations, each battery shall have a minimum of two (2) years remaining from the date of manufacture at delivery. Product documentation shall include battery specifications, safety data sheets (SDS), and other applicable product documentation at no separate charge. Packaging shall follow standard commercial practice and applicable safety and transportation regulations for lithium-based medical-grade components, including applicable DOT and IATA Dangerous Goods Regulations. Lot number and date of manufacture shall be marked on each package. Advance shipping notification shall include carrier, tracking information, and estimated delivery date, and delivery logistics shall be coordinated with the Government POC before shipment. The Government will accept the contractor's standard commercial warranty to the maximum extent practicable. The batteries are passive supply items with no embedded or companion software, no FDA network connection, and no storage or transmission of data. Requirements document is in the solicitation.
Files
| File | Type | Posted |
|---|---|---|
| Requirements_Document_Lithium_Batteries_CDRH-2026-135728 Final.docx | DOCX document | |
| Sources_Sought_Vendor_Response.xlsx | XLSX spreadsheet | |
| Sol_Doc75F40126Q00420.docx | DOCX document |
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