AIRWAY, SUPRAGLOTTIC

The contract solicits five units of a disposable supraglottic airway device designed as a simple-to-use alternative for patient ventilation, featuring a beveled distal tip to guide insertion posterior to the larynx and into the upper esophagus, with a dedicated channel allowing passage of a gastric tube. Each unit is size 5 with a purple tip, includes a 60cc syringe and lubrication, and measures 1.02 ft x .48 ft x 0.15 ft. The device is classified as a medical product regulated by the FDA, requiring compliance with registration, labeling, and good manufacturing practices though a 510(k) submission is not mandatory. The item has a fixed shelf life of 36 months, with a strict requirement that no more than five months have elapsed from the manufacturer's date to delivery. All packaging and labeling must adhere to the latest revision of the Medical Marking Standard No. 1 and MMS1A, including clear markings for manufacturer date, expiration or retest date, and contract or lot number. Packaging must conform to MIL-STD-2073-1E and MIL-STD-129, with palletization governed by DLA’s RP001 requirements. Delivery is required within 84 days of order receipt under FOB Destination terms, with no variance permitted in quantity. The supply is procured under NAICS code 339112 through a request for quotations issued by the Department of Defense’s Medical Supply Chain, with the solicitation number SPE2DS-26-T-111X and response deadline of June 8, 2026. Compliance with FAR and DFARS clauses is extensive, including cybersecurity safeguards under 252.204-7012 and 52.240-93 with deviations, restrictions on covered telecommunications equipment, whistleblower protections, prohibition of mandatory arbitration, and adherence to the Buy American Act and Berry Amendment. Offerors must maintain active SAM registration, submit certifications regarding small business status, and comply with hazard communication standards for any applicable materials. All items are subject to destination inspection under FAR 52.246-2, and receiving reports must meet DFARS Appendix F standards. Payment processing is exclusively through Wide Area Workflow, with adherence to routing data requirements and the Federal Acquisition Regulation's allowable cost and payment clause.