Tag: breathdirect

breathdirect bdr 19
PAP Therapy & Ventilation Systems

BreathDirect’s BDR-19 Critical Care Ventilator Receives FDA Emergency Use Authorization

Medical design firm, Nectar Product Development, and its affiliated medical device company, BreathDirectTM, announced that its BDR-19TM ventilator has received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Approval of the BDR-19TM for the critical care of patients with ventilatory insufficiency comes after an extended review process by FDA regulators […]

breathdirect bdr 19
PAP Therapy & Ventilation Systems

BreathDirect Passes UL Independent Testing for Low-Cost, U.S. Built BDR-19 Ventilator

California-based medical device company BreathDirectTM, developers of an affordable, full-service ventilator designed in response to COVID-19, announced that Underwriters Laboratory, the world’s largest independent testing organization, has completed testing of the BDR-19©, evaluating its safety and performance to treat ventilatory insufficiency. UL determined that the BDR-19© meets the criteria established in the […]