Saline Lock Kit Manufacturer / Medical Device Supplier

The contract requires the manufacture and supply of sterile, single-use Saline Lock Kits that meet stringent regulatory standards, including FDA 510(k) clearance and compliance with 21 CFR 880.5570, ensuring they are classified as Class II medical devices. All kits must be produced under Good Manufacturing Practices (GMP) to guarantee consistency, sterility, and safety for clinical use. The components within each kit must be precisely specified and assembled to function reliably in intravenous access scenarios, with no room for deviation in materials, sterility, or integrity. This is a subcontract opportunity under the Department of Defense’s Medical Supply Chain, with the solicitation posted on July 20, 2026, and responses due by July 27, 2026. The North American Industry Classification System code 325620 identifies this as a medical equipment and supply manufacturing activity. The place of performance and exact delivery location are not specified, but the supplies are intended for U.S. military medical operations. The procurement is open to qualified manufacturers capable of scaling production while maintaining full regulatory adherence, and bidders must demonstrate proven capability in sterile medical device production. The detailed submission requirements and technical specifications are accessible through the provided DIBBS link.