Device Dossier
Stationary oxygen concentrator
Device Dossier for Stationary oxygen concentrator (Stationary oxygen concentrator, Class IIb, sponsor Marquard Ventures). ARTG record, intended purpose,…
- GMDN category: Stationary oxygen concentrator
Intended purpose
The oxygen concentrator is a portable medical device intended for adult patients who require supplemental oxygen on a prescriptive basis. It extracts and concentrates oxygen from ambient air and delivers it—typically through a nasal cannula—at high oxygen concentrations to support oxygen therapy. The device is suitable for use in home, healthcare, hospital, or institutional environments. It serves as an oxygen supplement only and is not intended to be life-supporting, life-sustaining, or to provide any patient-monitoring capabilities.