INTRODUCER KIT, GUIDEWIRE, CARDIOVASCULAR

The contract solicits two packages of an Introducer Kit, Guidewire, Cardiovascular, each package containing five units, as specified by NSN 6515016659129, intended for use with Cardiac Pacemaker, Single Chamber. Each kit includes a comprehensive set of cardiovascular intervention supplies: a 5 FR temporary pacing catheter, 6 FR x 4" sheath, marked spring-wire guide, 18 GA catheter, injection needles in 22 GA and 25 GA sizes, an 18 GA introducer needle, syringes in 0.75 CC, 3 mL Luer-lock, and 5 mL Luer-slip formats, applicator pouches with 2% CHG and 70% IPA, a 5 mL ampule of 1% lidocaine solution, a foil pack of 10% povidone-iodine ointment, adapters, dust caps, a catheter contamination shield, CSR wrap, two drapes (one with a fenestration), an alligator clip, a number 11 scalpel, a three-way high-flow stopcock, gauze pads in 2" x 2" and 4" x 4" sizes, and a 3-0 braided silk suture with a straight needle. The item is classified as a FDA-regulated Class II medical device with a non-extendable 18-month shelf life, and no more than three months may have elapsed from the manufacturer’s date to the delivery date to the government. The kit must be packaged, marked, and labeled in compliance with MIL-STD-129 and the latest Medical Marking Standard No. 1, with packaging requirements superseding ASTM D3951 where conflicts exist, and must adhere to DLA Packaging Requirements RP001. Delivery is required within 20 days after receipt of order, FOB destination, to the USNS MERCY in FPO AP 96672-4090. The solicitation requires strict adherence to cybersecurity protocols, including DFARS 252.204-7012 for safeguarding covered defense information and DFARS 252.204-7018 prohibiting covered defense telecommunications equipment. Offerors must submit a Safety Data Sheet, represent their business size and socioeconomic status in SAM, and disclose any non-domestic