BAG, URINE COLLECTION

The contract requires the supply of sterile, individually sealed disposable urine collection bags with a 2000 mL capacity, each equipped with a plastic input and drain tube assembly, an anti-reflux valve in the drip chamber, and a hanger for attachment to beds, chairs, or patients. The unit of issue is a package (PG) of 20, with a total quantity of 3 packages ordered. The item is regulated by the FDA as a Class II medical device under Regulation 876.5250, requiring compliance with registration, labeling, and GMP standards, though a 510(k) premarket notification is not explicitly mandated. The product must have a 60-month shelf life with no more than nine months elapsed between the date of manufacture and delivery, and all containers must be marked with the lot number and manufacture date prefixed by “MFD.” Packaging must adhere to commercial standards as specified in the procurement document, conforming to MIL-STD-2073-1E for preservation, packing, and marking, and must follow Medical Marking Standard No. 1 (MMS No. 1), which supersedes MIL-STD-129 for medical items. Markings must include the required lot and manufacturing date information; hazardous or radioactive materials must still comply with MIL-STD-129 where applicable. Delivery is FOB destination to Fort Bliss, Texas, with a 20-day delivery window from order receipt, and inspection and acceptance occur at the destination. The contract mandates electronic invoicing through WAWF and compliance with NIST SP 800-171 for cybersecurity, as well as Hazard Communication Standard requirements for labeling hazardous materials, including pre-award submission of Safety Data Sheets. Contractors must represent their small business status and provide a Unique Entity Identifier and CAGE code, and must comply with labor and anti-trafficking clauses under FAR and DFARS. Pricing information is not provided in the solicitation, but the item is procured under NSN 6515-01-059-2473, and only approved suppliers such as The Kendall Company LP and Cardinal Health 200, LLC are referenced with their respective part numbers.