PROBE, TEMPERATURE MONITORING

The contract calls for the procurement of two single-use adult esophageal and rectal temperature monitoring probes, specifically the YSI model, with a unit of issue of each. The product must have a 36-month shelf life, and no more than seven months may have elapsed between the date of manufacture and the date of delivery to the government. Labels must clearly display the NSN, manufacturer, CAGE code, date of manufacture, expiration or retest date, and the contract or lot number. This medical device is regulated under FDA Regulation 880.2910 Class II and requires a 510(k) premarket notification, along with compliance with registration, listing, labeling, and GMP requirements. Packaging must adhere to commercial standards and the DLA Packaging Requirements for Procurement (RP001), with unit containers sealed to prevent damage and shipping containers suitable for safe delivery. Labeling must follow Medical Marking Standard No. 1, superseding MIL-STD-129, and all items must be marked in accordance with MMS No. 1 and the special marking code ZZ. The deliveries are to be made to APO 09094-3219 with a delivery deadline of 20 days after award, under FOB Destination terms, and the receiving point is designated as FM5612 86 MDSS SGSM UNIT 3219. Inspection and acceptance occur at the destination, governed by FAR 52.246-2, and the contractor must submit electronic receiving reports and invoices via WAWF. The contract incorporates requirements for whistleblower rights, cybersecurity safeguards, hazardous material identification, sustainable products, employment eligibility verification, combating human trafficking, and limitations on forced confidentiality agreements. The contractor must be registered in SAM, provide accurate representations regarding small business status, and may be required to disclose whether materials are domestic or foreign under the Berry Amendment and Buy American Act. Additive manufacturing is prohibited unless explicitly authorized. The contract also includes clauses addressing transportation by sea, reflagging or repair work, control of government work product, disclosure of information, and unenforceability of unauthorized obligations. A deviation applies to multiple clauses including combating trafficking, cybersecurity, changes, and hazardous materials, all effective under deviation 2026-O0038. The solicitation number is SPE2DS-26-T-236B, issued on July 15, 2026, with responses due by