TUBE, VASCULAR GRAFT

The contract specifies the procurement of two units of a 16.0 millimeter nominal diameter, straight tube vascular graft made from Hemashield knitted double velour material, intended for use in repairing aortic aneurysms and bypass procedures for occlusive disease. Each graft must exceed 30 centimeters in useful length and comply with FDA Class II regulations, including 510(k) premarket notification, registration, listing, and current Good Manufacturing Practices. The item is assigned NSN 6515-01-456-6811 and is classified as a Type I (Code Q) item with a non-extendable shelf life of 36 months. Packaging and labeling must adhere to MIL-STD-2073-1E and the Medical Marking Standard No. 1, which supersedes MIL-STD-129 for medical devices, ensuring proper preservation, sealing in unit containers, and use of commercial-grade outer shipping cartons. Hazardous material labeling must comply with OSHA’s Hazard Communication Standard, and any applicable materials must be disclosed with accompanying Safety Data Sheets prior to award. Delivery is required to FPO AE 09566-4008 aboard the USNS Comfort, with FOB Destination terms placing full transport responsibility on the contractor. All deliveries must be completed within 20 days of contract award. The solicitation mandates strict compliance with technical and quality requirements from the DLA Master List and includes numerous DFARS and FAR clauses governing employment practices, trafficking in persons, safeguarding government information, whistleblower rights, cybersecurity compliance with NIST SP 800-171, and transportation by sea using approved vessels. The contractor must provide a Unique Entity ID and CAGE code, disclose size status and socioeconomic certifications if applicable, and affirmatively report any provision of covered defense telecommunications equipment. Invoicing must be submitted via Wide Area WorkFlow, and final inspection and acceptance occur at the delivery point under FAR 52.246-2, with Government oversight confirmed by designated DoDAACs. While the contract type remains to be inserted and pricing is not specified in the solicitation, the estimated value is based on prior procurement data for the same NSN. All proposals must be submitted through the DIBBS portal by the July 27, 2026 deadline, with no alternative submission methods permitted, and must include complete technical documentation supporting compliance with all referenced standards and regulatory requirements.