BLOOD COLLECTING UNIT

The contract solicits 200 units of a winged blood collecting device with a 23-gauge, 12-inch configuration, classified as a medical device regulated by the FDA under 21 CFR 862.1675 as a Class II device, requiring compliance with registration, listing, labeling, and good manufacturing practices despite the absence of a 510(k) clearance requirement. The unit of issue is one pack (PG), containing 200 individual units, and the procurement is tied to NSN 6630-01-378-0273 with a delivery deadline of 20 days after order placement, to be shipped to Fort Stewart, Georgia. All packaging must align with DLA’s RP001 packaging requirements and Medical Marking Standard No. 1 (MMS NO. 1), which supersedes MIL-STD-129 for medical items; each unit must be sealed in a protective container and packed in commercial-grade shipping containers suitable for safe, cost-effective delivery by common carriers, with export packaging applied when necessary. The product must be marked in strict compliance with MMS NO. 1 and all packaging must meet ASTM D3951 standards unless overridden by the DLA Master List of Technical and Quality Requirements, referenced via RA001. The contract includes mandatory federal acquisition regulation clauses covering equal opportunity, employment eligibility verification, combating human trafficking, cybersecurity safeguards, hazardous material identification, export controls, and prohibition on acquiring equipment from Communist Chinese military companies. The contracting officer must refer the bid to a product specialist via EBS to confirm FDA regulatory compliance, providing bidder and manufacturer details. Payment processing is mandated through WAWF, requiring contractor registration in SAM, and delivery terms are FOB destination, placing full responsibility for transit risks and costs on the contractor. The solicitation is issued under SPE2DH-26-T-5223 with a response deadline of July 22, 2026, submitted exclusively via DIBBS, and includes clauses requiring representation of small business status and socioeconomic certifications under applicable statutes. No pricing information is provided in the solicitation, indicating the award will be determined post-submission, and no evaluation factors or scoring methodology are specified, suggesting award may follow a Lowest Price Technically Acceptable approach. The absence of formal attachments or detailed evaluation criteria means compliance with technical, packaging, labeling, and regulatory standards is paramount for acceptance.