Device Dossier
Anaesthesia face mask, non-scavenging, single-use
Device Dossier for Anaesthesia face mask, non-scavenging, single-use (Anaesthesia face mask, non-scavenging, single-use, Class IIb, sponsor AMBU). ARTG…
- GMDN category: Anaesthesia face mask, non-scavenging, single-use
Intended purpose
The Ambu face masks (Ambu Disposable Face Mask and Ambu King Mask) are disposable face masks intended for oxygenating and ventilating the airways and/or to direct anaesthesia to the upper airways. The device is for use in hospital and pre-hospital (EMS) environments. For use by CPR and/or medical professionals trained in airway management only.