Device Dossier

High-flow heated humidifier

Device Dossier for High-flow heated humidifier (High-flow heated humidifier, Class IIa, sponsor Taleb Medical and Vetequip). ARTG record, intended…

Intended purpose

A mains electricity (AC-powered) device designed to deliver high-flow (typically up to 50 L/min) heated/humidified ambient air or air/oxygen to a patient with respiratory disorders [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. The gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostomy. It typically consists of a gas flow generator, a heating element, provisions for attaching a humidification chamber, and tubing set. Healthcare providers prescribe the therapy, configure the breathing system, and adjust the patient settings; the device may be used in the hospital or home for spontaneously breathing patients.

TGA Public Summary