BLADE, LARYNGOSCOPE, MILLER

The contract specifies the procurement of a Miller No. 0 laryngoscope blade designed for newborn infants, manufactured by Henry Schein, Inc. with part number 8575362, and identified by NSN 6515-01-396-2848. The device is a sterile, disposable, stainless steel fiberoptic blade intended for use with standard fiberoptic handles and is regulated by the FDA as a Class II medical device under regulation 876.1500. Although a 510(k) submission is not explicitly required, compliance with FDA labeling, registration, listing, and good manufacturing practices is mandatory. The item is classified as a Fleet Prime Vendor Item, and bidders must clearly identify the source and part number being supplied. Packaging must adhere to Commercial Packaging standards and Medical Marking Standard No. 1, superseding MIL-STD-129, with each unit sealed in a protective container and shipped in suitable exterior packaging to ensure safe delivery via common carrier at the lowest cost. Delivery is required within 20 days FOB destination, with zero tolerance for quantity variance, and inspection and acceptance occur at the delivery point. The solicitation number is SPE2DS-26-T-023P, issued by the Department of Defense’s Medical Supply Chain for the Cannon AFB location, with a response deadline of May 4, 2026, and a single unit quantity at a unit price of $1.00.