SAM #75F40126Q00420

FDA Solicitation for Implantable Medical-Grade Primary Lithium Batteries

The U.S. Food and Drug Administration (FDA), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP), is seeking offers for implantable medical-grade primary lithium batteries for laboratory testing. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Office of Science and Engineering Laboratories (OSEL) - Division of Biomedical Physics (DBP) - Products Requested: - Twenty (20) new and unused implantable medical-grade primary lithium batteries (Li/SVO-CFx chemistry) - 10 high-rate batteries: - Rated capacity: 1.70–1.90 Ah - Stainless steel case, negative case polarity, molybdenum or equivalent terminal - Hermetically sealed, weight ≤17 g, volume ≤6.5 cc, specific dimensions - Capable of pulse discharge with defined load and pulse parameters - Storage temperature: –20°C to +60°C - 10 medium-rate batteries: - Rated capacity: 4.80–5.00 Ah - Titanium case, negative case polarity, titanium or equivalent terminal - Hermetically sealed, weight ≤22 g, volume ≤12.5 cc, specific dimensions - Capable of medium-rate sustained discharge with pulsing - Operating temperature: 37°C nominal; storage temperature: –20°C to +60°C - All batteries must be from the same manufacturing lot - At least two years remaining from date of manufacture at delivery - Product documentation required: battery specifications, safety data sheets (SDS), and other applicable documentation - Unique/Notable Requirements: - Batteries are for laboratory testing only (not for implantation) - Compliance with safety and transportation regulations for lithium-based medical-grade components - Delivery schedule: medium-rate batteries within 30 days after award; high-rate batteries within 180 days after award - Latest acceptable delivery date specified - Documentation, packaging, and warranty requirements - OEMs and Vendors: - No specific OEMs, brands, or vendors are named; any manufacturer meeting the salient characteristics may offer - No services are requested beyond product documentation

Description

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.

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