MONITORING SET, VASCULA

The contract is for the procurement of a disposable vascular pressure monitoring set, NSN 6515-01-407-2821, manufactured by Edwards Lifesciences LLC under part number PXvMP160, containing a pressure transducer, IV set, flush device, three-way stopcock cap, non-vented cap, 5 cc blood reservoir, reservoir mounting plate, sampling site, and three lengths of pressure tubing (10, 6, and 48 inches), along with a shut-off valve. The item is classified as a Type I (Code K) medical device with an 18-month non-extendable shelf life and must comply with FDA Regulation 870.2870 Class II, including registration, labeling, and GMP requirements regardless of 510(k) status. All units must be packaged in commercial packaging per MIL-STD-2073-1E and marked according to Medical Marking Standard No. 1, superseding MIL-STD-129. The contract mandates delivery of one package of ten units to APO AP 96264-2022 and Kunsan AB, Korea, with a five-day delivery lead time and FOB destination terms. Compliance with the Buy American Act and Berry Amendment is required, and the contractor must adhere to DLA’s Technical and Quality Master List for all R and I number specifications. The contracting process is governed by the DLA Master Solicitation for Automated Simplified Acquisitions Revision 105, and submissions must be through DIBBS. The contract incorporates multiple FAR and DFARS clauses mandating cybersecurity compliance via NIST SP 800-171, hazardous material safety data submission, Combating Trafficking in Persons, Employment Eligibility Verification, Equal Opportunity for Workers with Disabilities, and sustainable products requirements, with deviations applied in February 2026 for several clauses. Contractors must maintain active System for Award Management (SAM) registration, provide UEI and CAGE codes for joint ventures, and use WAWF for all invoicing, including required documents based on line item type. All deliveries are subject to destination inspection under FAR 52.246-2, and the order is designated as a DX or DO rated priority under DPAS. The solicitation closed on July 20, 2026, with award anticipated for the same NAICS code 339112 without