NEEDLE, HYPODERMIC

The solicitation seeks sterile hypodermic needles, 18 gauge by 1-1/2 inches with Luer Lock, packaged in quantities of 100 per unit, under NSN 6515-00-754-2834. The item is classified as a Type I (Code S) medical device with a non-extendable shelf life of 60 months and must comply with FDA Regulation 880.5570 as a Class II device, requiring a 510(k) clearance, registration and listing, labeling adherence, and good manufacturing practices. Packaging must meet commercial standards per ASTM D3951 and DLA-specific requirements, with each unit sealed in protective containers and shipped in commercial exterior containers suitable for safe transit by common carrier to Joint Base Lewis McChord, Washington. Marking must adhere strictly to Medical Marking Standard No. 1, which supersedes MIL-STD-129, and all labeling of hazardous materials must comply with the Hazard Communication Standard unless exempted by specific federal acts. The product must be delivered within 20 days of award under FOB Destination terms, and acceptance will occur at the delivery point with inspection governed by FAR 52.246-2. Bidder submissions via DIBBS must include the manufacturer name, part number, item description, and contact details, with a mandatory Safety Data Sheet submitted prior to award; failure to provide this results in disqualification. All offers must conform to the DLA Master Solicitation for Automated Simplified Acquisitions, Revision 105, which incorporates numerous FAR and DFARS clauses, including those on cybersecurity (DFARS 252.204-7012), combating trafficking, employment eligibility verification, sustainable products, and prohibitions on covered telecommunications equipment. The solicitation is designated as a small business set-aside, requires electronic invoicing through WAWF, and mandates compliance with SAM registration for payment processing. The contracting officer is James Burke, and technical and quality requirements are drawn from the DLA Master List of Technical and Quality Requirements.