Device Dossier

Oxygen therapy delivery system

Device Dossier for Oxygen therapy delivery system (Oxygen therapy delivery system, Class IIa, sponsor Getinge). ARTG record, intended purpose, GMDN…

Intended purpose

A single use product for nCPAP therapy / non invasive ventilation therapy in treating neonates and premature infants in intensive care units. In such cases, the device serves as the patient interface. It is used in combination with a ventilator, which controls the nCPAP pressure and supports the device with the necessary gas flow

TGA Public Summary