FLASHLIGHT, DIAGNOST

The contract is for the procurement of 18 diagnostic flashlights (3 packs of 6 units each) under NSN 6515-01-647-5068, specified as a white, translucent, fixed, clip-on device with a single disposable LED that delivers high-intensity light without requiring battery or bulb replacement. The product is intended for use by medical personnel including physicians, nurses, technicians, and paramedics and is classified as a Class I medical device regulated by the FDA under regulation 880.6350, requiring compliance with registration, listing, labeling, and GMP requirements though no 510(k) submission is mandated. The flashlights must be manufactured and delivered with no more than two months of shelf life elapsed from the date of manufacture to delivery, and have a non-extendable shelf life of 12 months. All packaging must comply with commercial standards and Medical Marking Standard No. 1, superseding MIL-STD-129 for medical items, and must include the manufacturer, CAGE code, lot number prefixed by “MFD,” date of manufacture, and expiration or retest date. Palletization must adhere to DLA Packaging Requirements for Procurement (RP001), and packaging must conform to ASTM D3951 unless superseded by the DLA Master List of Technical and Quality Requirements. The items must be delivered FOB destination to USS MILIUS DDG 69 at FPO AP 96672 within 20 days of the delivery order, with no variance allowed in quantity. The contract requires the bidder to specify the source and part number and to disclose UEI and CAGE codes if offering covered defense telecommunications equipment. Cybersecurity compliance is required under DFARS 252.204-7012, including safeguarding covered defense information and reporting cyber incidents, along with adherence to NIST SP 800-171 assessment requirements. The contract prohibits the use of covered telecommunications equipment from specified foreign vendors and mandates compliance with the Buy American Act and other socioeconomic requirements. Payment processing will occur via Wide Area WorkFlow (WAWF), and all deliveries must be labeled and traced with barcoding per medical marking standards. The contracting officer will determine the specific contract type, and the acquisition is governed by simplified acquisition procedures with applicable class deviations in effect.