Device Dossier
High-flow heated humidifier
Device Dossier for High-flow heated humidifier (High-flow heated humidifier, Class IIb, sponsor Emergo). ARTG record, intended purpose, GMDN category —…
- GMDN category: High-flow heated humidifier
Intended purpose
The respiratory high-flow therapy device is intended for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2-80/90 L/min depending on the patient interface. The device is for adults and children (age 1 month or more & Weight 3 kg or more) by prescription in hospitals and long-term care facilities. The device is not intended for life support. The device is a restricted medical device intended for use by qualified, trained professionals only. Untrained operators may setup the device inadequately which can result in patient injury or death.