ARTG 476413LungFit PH System - Gas administration system, nitric oxide
ARTG ID: 476413 · Getz Healthcare Pty Ltd · Beyond Air Inc · Class IIb · Started January 22, 2025
Good Name: Getz Healthcare Pty Ltd - LungFit PH System - Gas administration system, nitric oxide
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 476413
- Start Date
- January 22, 2025
- Effective Date
- January 22, 2025
- Name
- Beyond Air Inc
- Country
- United States of America
- Address
- 900 Stewart Ave Suite 301, Garden City, NY, 11530
The LungFit PH is intended to deliver nitric oxide, a vasodilator, generated by the device into the inspiratory limb of the patient breathing circuit of a ventilator in a way that provides a constant concentration of nitric oxide, as set by the user, to the patient throughout the inspired breath. The LungFit PH provides continuous integrated monitoring of O2, NO2 and NO and a comprehensive alarm system.
Access comprehensive regulatory information for LungFit PH System - Gas administration system, nitric oxide in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 476413 and sponsored by Getz Healthcare Pty Ltd, manufactured by Beyond Air Inc in United States of America. The device registration started on January 22, 2025.
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.