HEAT AND MOISTURE E

The contract pertains to a single-use heat and moisture exchanger designed for humidification, featuring a transparent housing for visibility, minimal dead space, and lightweight construction, suitable for tidal volumes ranging from 150 to 1500 ml. The device is regulated by the FDA as a Class I medical device under Regulation 868.5375, requiring compliance with registration, listing, labeling, and GMP standards despite not needing a 510(k) premarket notification. Each unit must be securely packaged in a sealed container to prevent damage, with outer shipping containers meeting commercial standards for safe, cost-effective delivery to the designated point, especially for international shipments. All packaging and labeling must strictly adhere to Medical Marking Standard No. 1, superseding MIL-STD-129, and must clearly display the manufacturer’s date, expiration date, contract number, and lot number consistent with the latest revision of MMS1A. The item has a mandatory 60-month non-extendable shelf life, with no more than nine months allowed to have elapsed from manufacture to government delivery. The unit of issue is a package (PG), with one package containing 20 units, and the contract specifies a total of two packages. The NSN is 6515-01-477-0878, with the contract number SPE2DS-26-T-298C and solicitation issued on August 2, 2026, requiring responses by August 10, 2026. Delivery is due within 20 days FOB destination, with no tolerance for variance in quantity. Inspection and acceptance occur at the destination, and packaging must comply with MIL-STD-2073-1E. Technical and quality requirements referenced by R and I numbers are governed by the DLA Master List, with the version in effect on the solicitation issuance date controlling. The item is sourced from Teleflex LLC and Southern Safety Sales, Inc., with part number 14412, and the contract involves covered defense information under RD003. The contracting official must submit an electronic referral via EBS to confirm regulatory compliance, including manufacturer and bidder details.