FLASHLIGHT, DIAGNOSTIC

This contract specifies the procurement of 7 packaging groups, each containing six diagnostic flashlights, for delivery to Fort Bliss, Texas, with a required delivery date of July 31, 2026. The flashlights are disposable, single-use devices featuring a bright white LED that requires no battery or bulb replacement, making them compact, lightweight, and ready for immediate use by medical personnel including physicians, nurses, technicians, and paramedics. The product is classified as a Class I medical device under FDA regulation 880.6350, requiring compliance with registration, listing, labeling, and GMP standards, though a 510(k) premarket notification is not mandated. Strict packaging and labeling requirements apply, including adherence to Medical Marking Standard No. 1 (superseding MIL-STD-129), ASTM D3951, and DLA packaging guidelines. All packaging must clearly display the manufacturer, CAGE code, date of manufacture prefixed with “MFD”, expiration date, contract number, and lot number. The items are subject to a non-extendable 12-month shelf life, with no more than two months permitted to have elapsed between manufacture and government delivery. The purchase is for a fixed quantity with zero variance allowed, delivered FOB destination, inspected and accepted at the delivery point, and must be shipped via traceable means excluding parcel post. The supplier must provide the source and part number, and the contract references applicable technical and quality requirements from the DLA Master List, which take precedence over all other standards.