FLASHLIGHT, DIAGNOSTIC

The contract is for the procurement of a disposable diagnostic flashlight featuring a white, translucient, fixed design with a clip and a single high-intensity LED light source, engineered to deliver bright, low-drain illumination without the need for 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 under FDA Regulation 880.6350, requiring compliance with registration, listing, labeling, and GMP standards despite the absence of a 510(k) requirement. The item must meet stringent quality and packaging standards as defined by the DLA Master List of Technical and Quality Requirements, which supersede all other standards including ASTM D3951. The flashlight is designated as a Type I (Code H) item with a non-extendable shelf life of 12 months, and no more than two months of that shelf life may have elapsed from the date of manufacture to the time of government delivery. All packaging must be commercial grade and individually sealed to protect against damage, with exterior shipping containers ensuring safe transport by common carriers. Labeling must comply with Medical Marking Standard No. 1, which replaces MIL-STD-129, and must include the NSN, manufacturer and CAGE code, date of manufacture prefixed by “MFD”, lot control number, and expiration or retest date. The contract mandates delivery of 1 packing group containing 6 units to the Naval Diving and Salvage Training Center in Panama City, Florida within 20 days of order placement under FOB Destination terms, with inspection and acceptance occurring at the destination. Quotations must be submitted via DIBBS by August 17, 2026, and bidders are required to provide the manufacturer's part number, company name, Safety Data Sheet, and hazard labeling where applicable. The solicitation is a small business set-aside under NAICS code 339113, employs automated simplified acquisition procedures per DLA Master Solicitation Revision 105, and incorporates a comprehensive suite of FAR and DFARS clauses addressing cybersecurity, ethical conduct, environmental compliance, export control, and contractor accountability, with electronic invoicing through WAWF required for payment processing.