INSERTION KIT, CHEST

The contract calls for the procurement of 117 sterile, single-use emergency chest tube insertion kits, each designed for rapid deployment at or near the point of injury to treat pneumothorax or hemothorax. Each kit must contain exactly eleven components: a 36 Fr chest tube, a wound seal kit, a Heimlich valve, primed gauze, a Heagar-Mayo needle driver, two 9-inch Rochester Peans, two 0 silk FSL 3-0 sutures, petroleum gauze, and a No. 10 scalpel. All components must be packaged together in a 3.5 mil nylon poly barrier bag and vacuum-sealed to maintain sterility. The kits must have a shelf life of 36 months, non-extendable, with no more than six months elapsed from the date of manufacture to the date of delivery to the government. Packaging and marking must comply with MIL-STD-2073-1E and MIL-STD-129, as well as the latest edition of the Medical Marking Standard No. 1. Any hazardous materials included must be labeled in accordance with OSHA’s Hazard Communication Standard, and containers with radioactive materials must meet the specific marking requirements outlined in MIL-STD-129. Delivery is required within 84 days after order placement to a designated destination in APO, with FOB destination terms applying. The contract is a Service-Disabled Veteran-Owned Small Business/Small Business Set-Aside, and only eligible certified vendors may respond. Offerors must be registered in the System for Award Management and must affirm their compliance with all applicable socioeconomic, anti-trafficking, and employment eligibility requirements. The kits are classified as Class I medical devices requiring FDA 510(k) clearance and adherence to good manufacturing practices. Contractors must comply with the Berry Amendment and Buy American Act restrictions, and are subject to DFARS cybersecurity requirements under NIST SP 800-171. All bids must be submitted electronically through the DLA Internet Bid Board System, and successful contractors must use Wide Area Workflow for payment submissions. Items produced using additive manufacturing are ineligible for award, and all components must be sourced from domestic or approved sources. Failure to meet any specification, including shelf life, packaging, or component composition, will result in rejection.