Device Dossier

Breathing circuit, anaesthesia, single use

Device Dossier for Breathing circuit, anaesthesia, single use (Breathing circuit, anaesthesia, single use, Class IIa, sponsor GE Healthcare). ARTG…

Intended purpose

A non-sterile assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient, typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are also devices typically employed in the circuit but may not be a part of this device. This is a single-use device.

TGA Public Summary