Device Dossier

Mask, air/oxygen

Device Dossier for Mask, air/oxygen (Mask, air/oxygen, Class IIa, sponsor Taleb Medical and Vetequip). ARTG record, intended purpose, GMDN category —…

Intended purpose

A malleable cylinder placed over the nose and mouth intended to deliver air/oxygen gases to a patient's airway in critical care areas, home care, hyperbaric chamber and any respiratory care environments. This device is typically non-conductive and is available in a range of sizes. It may include a head strap and various connectors and valves. It is available in different series for two applications. One autoclavable reusable version and another version non-autoclavable single patient use. However, it can be re-used repeatedly on single patient. More specifically the masks are used for Non-Invasive Ventilation (NIV) through Ventilation devices including Bi-Level Positive Airway Pressure (BIPAP), Continuous Positive Airway Pressure (CPAP), Automatic Positive Airway Pressure (APAP), Home Care Ventilators (HC), Anaesthesia Ventilators, Intensive Care (ICU) Ventilators, Hyperbaric Chamber and other critical care ventilators.

TGA Public Summary