CATHETER, URETHRAL

This contract specifies the procurement of disposable siliconized rubber Foley urinary catheters, 18 French, 3-way, with a 5 mL balloon and valve, sterilized and packaged in boxes of twelve. The item is identified by NSN 6515-00-104-8695 and is regulated by the FDA, requiring pre-award confirmation through the EBS system with manufacturer and bidder details. The catheters must meet stringent medical device specifications, including a non-extendable shelf life of 60 months under RS001 for Type I items. Packaging and marking must comply with Medical Marking Standard No. 1, which supersedes MIL-STD-129, and packaging data must adhere to MIL-STD-2073-1E, with unit containers sealed to protect against damage and shipping containers suitable for safe, cost-effective transport to destination points. All units must be marked per MMS NO. 1 guidelines, with palletization following DLA’s RP001 packaging requirements. The contract prohibits intentional addition of mercury or mercury compounds, with exceptions limited to specific functional uses governed by NAVSEA standards. Delivery is FOB destination within five days of order, with inspections and acceptances occurring at the delivery point. Four distinct CLINs are listed for the same item, each with a quantity of one box, but no unit or total prices are provided. The delivery destinations include Ramstein Air Base in Germany and APO AE 09094-3219 in the United States, with additional delivery points in Yokota Air Base, Japan. Invoicing must be submitted via Wide Area WorkFlow (WAWF), and the solicitation requires offerors to provide UEI and CAGE codes, represent small business status if applicable, and disclose compliance with clauses addressing trafficking in persons, employment eligibility, sustainable products, hazardous materials, and export controls. Special contractual requirements mandate compliance with OSHA’s Hazard Communication Standard for labeling, though exemptions apply for FDA-regulated products. The contract includes statutory and regulatory clauses under FAR and DFARS governing contract administration, payment, and technical compliance, ensuring alignment with Department of Defense procurement and medical supply chain standards.