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Breathing circuit, anaesthesia, single use

Access comprehensive regulatory information for Breathing circuit, anaesthesia, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by GE Healthcare Australia Pty Ltd, manufactured by Flexicare Medical Ltd in United Kingdom. The device registration started on May 07, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class IIa
Class IIa
Breathing circuit, anaesthesia, single use
Australia TGA ARTG Registered Device
Good Name: GE Healthcare Australia Pty Ltd - Breathing circuit, anaesthesia, single use
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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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 07, 2024
Effective Date
May 07, 2024
Manufacturer
Country
United Kingdom
Address
Cynon Valley Business Park, Mountain Ash, CF45 4ER