ARTG 4138937450 Series V2 Mask - Transparent face mask, reusable
ARTG ID: 413893 · MGC Diagnostics Australia Pty Ltd · Hans Rudolph Inc · Class IIa · Started July 21, 2023
Good Name: MGC Diagnostics Australia Pty Ltd - 7450 Series V2 Mask - Transparent face mask, reusable
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 413893
- Start Date
- July 21, 2023
- Effective Date
- July 21, 2023
- Name
- Hans Rudolph Inc
- Country
- United States of America
- Address
- 8325 Cole Parkway, Shawnee, KS, 66227
The 7450 series face mask is a reusable, multi-patient, multi-use mask intended for use with two-way non-rebreathing valves or other mask adapters for connection with flow measuring instruments used in lung function testing procedures with spontaneous breathing adults (>30 kg) in hospitals and other clinical settings by individuals that have at least minimal training or instructions on the use of the mask as well as the devices to which the mask is intended to connect. Applications are for pulmonary function testing, exercise testing and respiratory research. The masks, valves, adapters and headgear are supplied clean, non-sterile.
Access comprehensive regulatory information for 7450 Series V2 Mask - Transparent face mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 413893 and sponsored by MGC Diagnostics Australia Pty Ltd, manufactured by Hans Rudolph Inc in United States of America. The device registration started on July 21, 2023.
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.