Device Dossier
High-flow heated humidifier
Device Dossier for High-flow heated humidifier (High-flow heated humidifier, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN category —…
- GMDN category: High-flow heated humidifier
Intended purpose
The device is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. The device provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The device is not intended to provide total ventilatory requirements of the patient and not for use during field transport.