HEAT AND MOISTURE E

The contract is for the procurement of Heat and Moisture Exchangers, specifically 2-part humid-vent devices designed for single use with transparent housings, small dead-space, and lightweight construction, suitable for tidal volumes between 150 and 1500 mL. Each unit must be packaged in a sealed container to prevent damage and shipped in commercial exterior containers ensuring safe, cost-effective delivery via common carriers, with export packaging as needed. The item is classified as a Type I (Code S) medical device with a mandatory non-extendable 60-month shelf life, and no more than nine months may have passed between the manufacturer’s date and government delivery. Labeling must strictly follow Medical Marking Standard No. 1 (MMS No. 1), superseding MIL-STD-129, and include the manufacturer date, expiration or retest date, and contract or lot number, with shelf-life markings conforming to MMS1A. The unit of issue is a package (PG), with one package containing 20 units. The product is regulated by the FDA as a Class I device under regulation 868.5375, requiring compliance with registration, listing, labeling, and GMP standards, even though a 510(k) is not mandated. Packaging must adhere to ASTM D3951 unless overridden by DLA Master List requirements, and palletization must comply with RP001. The delivery point is the Naval Medical Readiness Logistics Command in Williamsburg, Virginia, with a firm delivery requirement within five days of award, FOB destination, and inspection and acceptance occurring upon arrival. The contract prohibits the use of parcel post and mandates shipment by traceable means. The solicitation number is SPE2DS-26-T-033A, with a response deadline of May 5, 2026, and submission must occur exclusively through the DLA Internet Bid Board System. Cybersecurity obligations under DFARS 252.204-7012 and NIST SP 800-171 apply due to the handling of covered defense information. The contract requires compliance with FAR and DFARS clauses related to employment equity, trafficking prevention, eligibility verification, sustainable procurement, and prohibition on certain internal confidentiality agreements. All submissions must include the bidder’s source and part number, and manufacturers are identified as Teleflex LLC with part number 14412 and Southern Safety Sales, Inc. The NS