Device Dossier
Oxygen concentrator
Device Dossier for Oxygen concentrator (Stationary oxygen concentrator, Class IIa, sponsor Macquarie Medical Systems). ARTG record, intended purpose,…
- GMDN category: Stationary oxygen concentrator
Intended purpose
The Mark5 Nuvo M5C5 is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life. It produces oxygen enriched product by concentrating the oxygen contained in room air. The prescribed daily duration and flow rate must be followed, otherwise it may present a risk to the patient?s health.