Emergency Use Ventilator
Designed with you, the Professional Care Team, in mind
The SuppleVent™ Ventilator is indicated to provide continuous ventilatory support of adult patients who require mechanical ventilation. It is a pressure-limited time-cycled ventilator intended to provide emergency use ventilation in a hospital environment for the duration of the COVID-19 pandemic.
The SuppleVent™ is a value-added, rapidly deployable ventilator inherently safe against over pressurization of the lungs. It is targeted at adult patients experiencing acute respiratory distress syndrome (ARDS) and other serious breathing difficulties related to COVID-19. The U.S. Food and Drug Administration granted BioMedInnovations LLC (BMI) with Emergency Use Authorization to begin manufacturing and distributing SuppleVent™, which is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes Intensive Care Unit (ICU) or other hospital environments including intra-hospital transport and temporary hospital facilities.
This ventilator has not been FDA cleared or approved and has been authorized by FDA under an EUA for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
