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Breathing circuit, ventilator, single use - ARTG 447713

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 registered under ARTG number 447713 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 447713
Class IIa
Breathing circuit, ventilator, single use
ARTG ID: 447713
Good Name: GE Healthcare Australia Pty Ltd - Breathing circuit, ventilator, single use
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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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
447713
Start Date
May 03, 2024
Effective Date
May 03, 2024
Manufacturer
Country
United Kingdom
Address
Cynon Valley Business Park, Mountain Ash, CF45 4ER