ARTG 422249CPAP/BiPAP nasal mask, single-use
ARTG ID: 422249 · Intersurgical Australia Pty Ltd · Pulmodyne Inc · Class IIa · Started September 22, 2023
Good Name: Intersurgical Australia Pty Ltd - CPAP/BiPAP nasal mask, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 422249
- Start Date
- September 22, 2023
- Effective Date
- September 22, 2023
- Name
- Pulmodyne Inc
- Country
- United States of America
- Address
- 2055 Executive Drive, Indianapolis, IN, 46241
The BiTrac Nasal mask is a comfortable and effective solution for non-invasive ventilation. Designed with a double-lipped silicone cushion, the BiTrac Nasal helps alleviate unnecessary pressure while achieving a great seal. The OmniClip technology allows for adjustable forehead pad positioning, while the headgear's two sets of Velcro ensure a perfect fit for patients of all head sizes.
Access comprehensive regulatory information for CPAP/BiPAP nasal mask, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 422249 and sponsored by Intersurgical Australia Pty Ltd, manufactured by Pulmodyne Inc in United States of America. The device registration started on September 22, 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.