Australia flagARTG 418209

Pulmonary function testing nasal mask

ARTG ID: 418209 · Bird Healthcare Pty Ltd · Hans Rudolph Inc · Class IIa · Started August 15, 2023

Good Name: Bird Healthcare Pty Ltd - Pulmonary function testing nasal mask

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
418209
Start Date
August 15, 2023
Effective Date
August 15, 2023
Sponsor
Manufacturer
Country
United States of America
Address
8325 Cole Parkway, Shawnee, KS, 66227
Intended purpose

Intended to be a reusable, multi-patient, multi-use face mask, used in conjunction with 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.

About this record

Access comprehensive regulatory information for Pulmonary function testing nasal mask in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 418209 and sponsored by Bird Healthcare Pty Ltd, manufactured by Hans Rudolph Inc in United States of America. The device registration started on August 15, 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.

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