PLEDGETS, CARDIOVASC

The contract calls for the procurement of 36 packages of sterile cardiovascular pledgets, each package containing six pledgets, for a total of 216 individual pledgets, with a unit of issue defined as a package. The pledgets must measure 1/4 inch by 1/8 inch by 1/16 inch and comply with the NSN 6515-01-482-9080, adhering to Regulation 870.3470 Class II and associated medical device marketing requirements including 510(k) submission, GMP compliance, and labeling standards. A strict shelf life of 60 months is required, with no more than nine months elapsed between the date of manufacture and the date of delivery to the government. All materials must be marked in accordance with Medical Marking Standard No. 1, superseding MIL-STD-129, and must include the NSN, manufacturer name, CAGE code, date of manufacture, expiration or retest date, and the contract and lot number. Packaging must be commercial-grade, using sealed unit containers and suitable exterior shipping containers that ensure safe delivery at the lowest possible rate, with preservation and packing conforming to MIL-STD-2073-1E as specified in Special Packaging Instructions MPWN00001. The delivery must be made within 20 days after the order date, with a required delivery date of May 22, 2026, to FOB Destination at Hurlburt Field, Florida. Shipping must be traceable and cannot use parcel post. The procurement falls under the NAICS code 339112 and is not a small business set-aside. The solicitation is executed under the DLA Master Solicitation for Automated Simplified Acquisitions Revision 104 and incorporates numerous FAR and DFARS clauses, including those governing cybersecurity (NIST SP 800-171, FAR 52.204-13, DFARS 252.204-7012), compliance with the Buy American Act and Berry Amendment, prohibitions on covered defense telecommunications equipment, whistleblower protections, and restrictions on mandatory arbitration agreements. Offerors must be registered in the System for Award Management, maintain active SAM representations, and use the Wide Area Workflow system for invoicing and receiving reports. Technical and quality requirements referenced by R or I numbers are sourced from the DLA