HEAT AND MOISTURE E

The contract calls for the procurement of a single-use heat and moisture exchanger designed for humidification, featuring a two-part humid-vent design with a transparent housing for enhanced visibility, minimal dead space, lightweight construction, and compatibility with 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 suitable for safe delivery via common carrier to the designated destination in San Antonio, Texas, under FOB destination terms with a strict five-day delivery requirement. The item must comply fully with Medical Marking Standard No. 1, which supersedes MIL-STD-129, and all labels must clearly indicate the manufacturer date, expiration or retest date, and contract or lot number, with shelf life markings conforming to MMS1A. The product has a non-extendable shelf life of 60 months, and no more than nine months may have elapsed between the manufacturer’s date and government delivery. The device is regulated as a Class I FDA medical device under Regulation 868.5375, requiring compliance with registration, listing, labeling, and GMP standards, though a 510(k) is not mandated. Packaging and preparation must follow MIL-STD-2073-1E and the special instructions MPWNN00001 Rev Dated 03/30/1988, with commercial packaging as specified. The unit of issue is a package (PG) of 20 units, and the total requirement is four packages. Contractors must submit quotes through the DIBBS system by the specified deadline and are prohibited from using additive manufacturing unless explicitly authorized. Failure to submit a required Safety Data Sheet or noncompliance with marking, labeling, or shelf life regulations will render the offer ineligible. The contract incorporates multiple DFARS clauses addressing cybersecurity, whistleblower rights, prior DoD official compensation, export controls, hazardous material handling, and prohibited procurement from certain Chinese military companies. Payment and invoicing must be processed electronically via WAWF, and destination inspection is required under FAR 52.246-2. The solicitation is not a small business set-aside and may proceed via automated award, with HUBZone preferences applied if applicable.