Oronasal Resuscitation Mask Manufacturing

The contract requires full manufacturing of a Class II medical device known as an oronasal resuscitation mask, which includes a transparent design with an oxygen inlet, an inflatable cuff, and a semi-rigid dome, along with all necessary accessories. The manufacturer must ensure full compliance with FDA regulations, ISO 13485 quality management standards, and Defense Logistics Agency requirements to meet military medical supply specifications. Production must be executed under strict quality control protocols to guarantee device safety, efficacy, and consistency across all units, as this device is intended for critical resuscitation applications in field and clinical environments. The solicitation is issued as a subcontract under the NAICS code 339112 for Medical Equipment and Supplies Manufacturing, with the Department of Defense’s Medical Supply Chain MD SURG FSF as the overseeing organization. The place of performance is designated as FPO with a ZIP code of 09587, indicating deployment to military locations requiring logistical flexibility. The response deadline is August 5, 2026, and the posting date is July 30, 2026, allowing a short window for qualified manufacturers to submit proposals. This procurement is part of a larger initiative to secure reliable, high-standard medical devices for U.S. military medical operations and does not specify any set-aside status for small or disadvantaged businesses.