HEAT AND MOISTURE E

The contract specifies the procurement of a single-use heat and moisture exchanger designed for humidification in medical applications, with a transparent housing for visibility, minimal 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 that ensure safe, cost-effective delivery to the destination point under FOB destination terms. Items must comply with Medical Marking Standard No. 1, replacing all prior references to MIL-STD-129, with labels clearly indicating the manufacturer date, expiration date, contract number, and lot number. The product has a non-extendable shelf life of 60 months, and no unit may be delivered to the government if more than nine months have passed since its manufacture. The unit of issue is a package containing twenty units, and the contract quantity is four packages. The item is regulated by the FDA as a Class I device under regulation 868.5375, requiring registration, listing, proper labeling, and good manufacturing practices despite not needing a 510(k). Packaging must meet MIL-STD-2073-1E standards, and all markings, labeling, and documentation must align with the latest revisions of MMS No. 1. The contract requires bidders to provide the source and part number, and the item is subject to potential covered defense information requirements. Delivery is due within twenty days, with zero variance allowed in quantity, and inspection and acceptance occur at the destination. The contractor is Teleflex LLC under part number 14412, supplied through Southern Safety Sales, Inc., with the NSN 6515-01-477-0878 and solicitation number SPE2DS-26-T-304B.