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Breathing circuit bag, reusable

Access comprehensive regulatory information for Breathing circuit bag, reusable 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 bag, reusable
Australia TGA ARTG Registered Device
Good Name: GE Healthcare Australia Pty Ltd - Breathing circuit bag, reusable
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Intended Purpose

:A non-sterile device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. Reservoir bags are made of high-compliance neoprene and are designed for manual ventilation of the patient. They can be connected directly, or via an extra limb, to the manual ventilation port of the anaesthesia ventilator. If the patient is not breathing correctly then the gas collected in the reservoir bag can be administered by squeezing, in order to support inhalation. This is a Reusable 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