Australia flagARTG 465046

Breathing circuit, ventilator, single use

ARTG ID: 465046 · Draeger Australia Pty Ltd · Dragerwerk AG & Co KGaA · Class IIb · Started October 21, 2024

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

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
465046
Start Date
October 21, 2024
Effective Date
October 21, 2024
Sponsor
Manufacturer
Country
Germany
Address
Moislinger Allee 53-55, Lubeck, 23542
Intended purpose

VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient. The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP. The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port. The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

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 IIb is registered under ARTG number 465046 and sponsored by Draeger Australia Pty Ltd, manufactured by Dragerwerk AG & Co KGaA in Germany. The device registration started on October 21, 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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