Intensive-care ventilator, general-purpose - ARTG 333747
Access comprehensive regulatory information for Intensive-care ventilator, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 333747 and sponsored by Rapp Australia Pty Ltd, manufactured by Beijing Aeonmed Co Ltd in China. The device registration started on April 08, 2020.
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.
The critical care ventilator is an electronically controlled, electronically powered machine, which is used in ICU for the critical care, in Respiratory Department or Emergency Department for the rescue and therapy of the patient with respiratory insufficiency, and in other departments for providing respiratory support for the patient. The ventilator is applicable for patients weighing at least 3 kg (7 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation. The ventilator is intended for use in hospital and hospital-type facilities. It may be used during intra-hospital transport provided that electrical power is supplied.