Device Dossier
Breathing circuit, anaesthesia, single use
Device Dossier for Breathing circuit, anaesthesia, single use (Breathing circuit, anaesthesia, single use, Class IIa, sponsor Flexicare). ARTG record,…
- GMDN category: Breathing circuit, anaesthesia, single use
Intended purpose
Anaesthesia Breathing Circuits are an assembly of devices that deliver medical gases and vapours, and oxygenation to the patient for anaesthesia, mechanical ventilation and ventilatory support. The circuits provide connections for devices that humidify, deliver medication and monitor gas concentration or pressure within the anaesthesia circuit. Anaesthesia Breathing Systems are intended for use by trained medical professionals on neonatal, paediatric, or adult patients, and are single use up to a maximum of 7 days, or for the duration of the procedure, whichever is shorter. Unless otherwise dictated by local hospital policy and local guidelines, adult anaesthesia breathing systems can be used on multiple patients provided a new Flexicare or other appropriately validated bacterial/viral breathing filter is used at the patient end of the system for each individual patient. In this case adult anaesthesia breathing systems are validated for a period of use up to 7 days or 10 operating lists, whichever is shorter.