INTRODUCER, ENDOTRACHEA

The contract is for the procurement of 4 packages, each containing 10 single-use, sterile, adult coude-tip endotracheal tube introducers (bougies), totaling 40 units. Each introducer is 70 cm in length, graduated, made of medical-grade plastic, and designed for use with endotracheal tubes ranging from 6.0 mm to 11 mm in diameter. The item is classified under NSN 6515-01-600-1648 and regulated by the FDA as a Class I device under regulation 868.5770, requiring a 510(k) submission for marketing compliance. The supplies must be disposable, sterile, and packaged in sealed unit containers with commercial exterior shipping packaging compliant with MIL-STD-2073-1E and marked strictly in accordance with Medical Marking Standard No. 1 (MMS No. 1), superseding MIL-STD-129. All labels must include the manufacturer date, expiration or retest date, and contract/lot number, with shelf life requiring a minimum of 60 months from manufacture and no more than 9 months elapsed from manufacture to delivery to the government, as defined by MMS1A. Delivery is required 20 days after order date (ADO) to the consignee at USNS COMFORT in FPO, AE 09566-4008, under FOB Destination terms. The contract incorporates multiple DFARS and FAR clauses covering cybersecurity, safety data, whistleblower protections, hazardous materials, export control, and transportation, including mandatory compliance with DFARS 252.204-7012 for safeguarding defense information and DFARS 252.240-7997 for NIST SP 800-171 assessments. Payment is exclusively electronic through WAWF, requiring both an invoice and receiving report. All bids must be submitted via the DIBBS portal by July 22, 2026, and failure to provide a Safety Data Sheet or complete technical data for any alternate offer will result in disqualification. The solicitation is not a small business set-aside, may proceed via automated award if no first article testing is required, and allows for HUBZone price preferences unless waived. Offerors must validate their representations in SAM, including small business status, and certify compliance with prohib