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Emergency CPAP set, non-nebulizing - ARTG 464225

Access comprehensive regulatory information for Emergency CPAP set, non-nebulizing in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 464225 and sponsored by Draeger Australia Pty Ltd, manufactured by Dragerwerk AG & Co KGaA in Germany. The device registration started on October 14, 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 IIb
ARTG 464225
Class IIb
Emergency CPAP set, non-nebulizing
ARTG ID: 464225
Good Name: Draeger Australia Pty Ltd - Emergency CPAP set, non-nebulizing
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Intended Purpose

The Seattle PAP plus system is intended to provide nasal continuous positive airway pressure (nCPAP) to patients weighing up to 10 kg (22 lbs) who qualify for non-invasive respiratory support. The system is intended to be used with the Fisher & Paykel MR850 humidifier. The system is for use in hospital environments such as neonatal intensive care units (NICU) and pediatric intensive care units (PICU).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
464225
Start Date
October 14, 2024
Effective Date
October 14, 2024
Manufacturer
Country
Germany
Address
Moislinger Allee 53-55, Lubeck, 23542