RESUSCITATOR, HAND O

The contract specifies the procurement of a hand-operated resuscitator, a bag-valve-mask device composed of an oxygen reservoir, supplemental oxygen attachment with supply tubing, a resuscitator bag, a one-way valve, and an adult-sized clear face mask (size 4). The unit of issue is each, and the item must have a 60-month shelf life with no more than nine months elapsed from the date of manufacture to the date of delivery to the government. Labels must include the NSN 6515-01-593-4841, manufacturer and CAGE code, date of manufacture, expiration or retest date, and contract or lot number; all containers must be marked with "MFD" followed by the lot and manufacture date. Bidders must identify their company and part number, with accepted offerings including Combat Medical Systems LLC’s P/N PBVM-G and Tribalco LLC’s P/N TICS.35.10445. The device is regulated by the FDA as a Class II medical device under regulation 868.5905, requiring 510(k) clearance along with registration, listing, labeling, and GMP compliance. All packaging must comply with DLA’s RP001 and Medical Marking Standard No. 1, superseding MIL-STD-129 and ASTM D3951, and must ensure protection from damage during transport. Units must be sealed in suitable commercial containers and packed for safe delivery by common carrier at the lowest cost to the destination specified. The item is to be shipped traceably—not via parcel post—to the Davenport, Iowa delivery point, with strict compliance to DLA packaging and marking standards. The contract mandates delivery within 20 days of the required delivery date of April 28, 2026, with zero quantity variance permitted. The solicitation number is SPE2DS-26-T-015Q, and all technical and quality requirements referenced in the DLA Master List take precedence. The contracting official must confirm FDA regulatory compliance via EBS referral before award.