20261015_Cell Salvage Supplemental_RFI_Response Form_2.xlsx

This is a Request for Information (RFI) Response Form for a cell salvage device evaluation being conducted by the Department of the Air Force Materiel Command (AFMEDCOM) under solicitation number FA800326SS004. The RFI seeks market research to identify solutions capable of performing cell salvage, blood conditioning, and autonomous return with flow rate control to bridge the time to surgery in austere environments. The government is interested in both existing cleared devices and prototypes from large businesses and all categories of small businesses.

The response form outlines ten essential characteristics that potential vendors must address, including: FDA approval status or clear pathway to approval; use of FDA-cleared consumable items; real-time monitoring of device fluid pressure; ability to recover from any orientation within three minutes; cleared control and monitoring systems; user-selectable collection and return rates up to 1500 mL/min; gas exchange capability with selectable sweep gas flow rates up to 10 L/min; integrated hypothermia prevention through heating capability; and specific thermal performance (heating 450 cc of fluid from 2°C to 37°C). Vendors must indicate whether their device meets each requirement and provide detailed comments. The NAICS code 339112 (Surgical and Medical Instrument Manufacturing) may be used for this requirement. This is a pre-solicitation market research effort, and responses do not constitute binding offers or contracts.