APPLICATOR, DISPOSAB

The item is a disposable, sterile cotton-tipped applicator with a wood shaft, measuring 5/64 inch in diameter and 6 inches in length, packaged in lots of 1,000 units per package, with the unit of issue being the package. Each unit is individually wrapped and must have a mandatory shelf life of 60 months from the date of manufacture, with no more than nine months elapsed between manufacture and delivery to the government. Packaging must comply with commercial standards and be designed to protect against damage and breakage, using sealed unit containers and appropriate exterior shipping containers suitable for safe transport via common carrier at the lowest rate. All items must be marked in accordance with Medical Marking Standard No. 1, superseding MIL-STD-129, with labels clearly showing manufacturer date, expiration date, contract number, and lot number as specified in MMS1A. The product is regulated by the FDA as a Class I device under regulation 880.6025, requiring registration, listing, labeling, and GMP compliance, even though a 510(k) is not mandatory. It is subject to DLA packaging requirements, and government identification must be removed from non-accepted supplies per RQ011. The NSN is 6515-01-017-2177, with a procurement quantity of one package containing 1,000 units, to be delivered FOB destination within 20 days with zero variance allowed. Inspection and acceptance occur at the destination, and packaging must conform to MIL-STD-2073-1E. The solicitation number is SPE2DS-26-T-004P, issued by the Department of Defense under NAICS code 339112, with performance directed to MCBH Kaneohe Bay, Hawaii.