Australia TGA ARTG record

Breathing circuit, ventilator, single use

Australia TGA ARTG Registered Device · GE Healthcare Australia Pty Ltd · Flexicare Medical Ltd · Class IIa · Started May 03, 2024

Good Name: GE Healthcare Australia Pty Ltd - Breathing circuit, ventilator, single use

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 03, 2024
Effective Date: May 03, 2024

Sponsor

Name: GE Healthcare Australia Pty Ltd

Manufacturer

Name: Flexicare Medical Ltd
Country: United Kingdom
Address: Cynon Valley Business Park, Mountain Ash, CF45 4ER

Intended purpose

: A non-sterile assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

About this record

Access comprehensive regulatory information for Breathing circuit, ventilator, 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 03, 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.