Inspired O2FLO™ Now Granted Emergency Use Authorization

Inspired Medical is pleased to announce that the U.S. Food and Drug Administration (FDA) has evaluated and determined that our O2FLO High Flow Respiratory Humidifier (VUN-001) meets the criteria for safety and performance. Inspired O2FLO™ has now been authorized and available for emergency use in healthcare settings to treat patients with hypoxemia and other acute respiratory symptoms. O2FLO also meets homecare safety requirements and is IEC60601-11 compliant.

 

Inspired O2FLO™ is a simple to use system for Nasal High Flow Therapy that delivers warmed and humidified respiratory gases with flow rates up to 60 LPM to spontaneously breathing patients.

 

High Flow Nasal Oxygenation is clinical recommended by the World Health Organization (WHO) and many other international Critical Care institutes for treatment of patients displaying mild to moderate SARI (severe acute respiratory symptoms) diagnosed with COVID-19.  Join us in the battle against COVID-19!

 

For more information about our products or enquiries, please email us at info@inspired-medical.com.

 

Click link to see the EUA authorization list – “Appendix B