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 —…

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.

TGA Public Summary