Device Dossier
Flow Safe II Disposable CPAP System - CPAP/BiPAP face mask, single-use
Device Dossier for Flow Safe II Disposable CPAP System - CPAP/BiPAP face mask, single-use (CPAP/BiPAP face mask, single-use, Class IIa, sponsor Quest…
- GMDN category: CPAP/BiPAP face mask, single-use
Intended purpose
Single-use non-sterile flexible form-shaped device to be placed over a user's nose to interface with a Continuous Positive Airway Pressure (CPAP) unit to provide the respiratory tract with direct air or medical oxygen and air at a higher pressure than air for non invasive positive pressure ventilation. Includes a built-in manometer, pressure & pressure relief valve, light weight contoured mask and elastic head harness for better seal and comfort, and Nebulizer. For use in the hospital and pre-hospital areas.