Advanced Perfusion System 1 - Heart-lung bypass system
Access comprehensive regulatory information for Advanced Perfusion System 1 - Heart-lung bypass system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Cardiovascular Systems Corporation in United States of America. The device registration started on December 03, 2019.
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 system is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The system incorporates both roller and centrifugal pumps as needed. The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only. It is a highly configurable modular system with a distributed network architecture that allows the user to customise the number and types of system specific components or modules, which can be configurable, displayed and controlled from a central monitor.