Australia TGA ARTG recordCollector, gas, expired
Australia TGA ARTG Registered Device · MGC Diagnostics Australia Pty Ltd · Hans Rudolph Inc · Class IIa · Started April 12, 2021
Good Name: MGC Diagnostics Australia Pty Ltd - Collector, gas, expired
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- April 12, 2021
- Effective Date
- April 12, 2021
- Name
- Hans Rudolph Inc
- Country
- United States of America
- Address
- 8325 Cole Parkway, Shawnee, KS, 66227
Intended for rebreathing studies. The Hans Rudolph non-diffusing gas bags are designed for respiratory studies that require collection of gases or delivery of gases that depend on their accuracy and the stability of the gas concentration in the collection bag. There is no validated method to disinfect the interior of the bag so the application is defined as single patient use for rebreathing studies.
Access comprehensive regulatory information for Collector, gas, expired in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by MGC Diagnostics Australia Pty Ltd, manufactured by Hans Rudolph Inc in United States of America. The device registration started on April 12, 2021.
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