ENHANCER, CIRCULATOR

Solicitation SPE2DS-27-T-1331 is a request for quotations issued by the Defense Logistics Agency Troop Support for the procurement of 10 units of the ResQPod Circulatory Enhancer, identified by NSN 6515-01-696-7098. This Class II medical device, regulated under FDA Regulation 868.5250, is designed to treat low blood flow conditions and requires compliance with 510(k) marketing requirements, registration, listing, and Good Manufacturing Practices. The items have a non-extendable shelf life of 48 months and must be delivered by November 4, 2026, under FOB Destination terms. The contract mandates strict adherence to medical marking standards, specifically Medical Marking Standard No. 1, and packaging requirements per MIL-STD-2073-1E and RP001. Inspection will be conducted at the destination. Administrative requirements include electronic invoicing via the Wide Area WorkFlow system and compliance with various FAR and DFARS clauses, including the Buy American Act, NIST SP 800-171 cybersecurity assessments, and hazardous material labeling standards. Offerors must provide a complete data package for any alternate part offers and validate their status through the System for Award Management.