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Nasal oxygen cannula, mouth outlet

Access comprehensive regulatory information for Nasal oxygen cannula, mouth outlet in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Respirtec Corporation, manufactured by Zhejiang Baite Medical Appliances Co Ltd in China. The device registration started on May 10, 2022.

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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Class IIa
Class IIa
Nasal oxygen cannula, mouth outlet
Australia TGA ARTG Registered Device
Good Name: Respirtec Corporation - Nasal oxygen cannula, mouth outlet
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Intended Purpose

A semi-rigid tube with nasal prongs and external mouth directed outlets intended for oxygen O2 administration. Oxygen is directed to flow simultaneously into the nostrils superiorly [ via nasal prongs situated within the nostrils, refer, nasal oxygen cannula, GMDN 117668 and ARTG ID 98874, Bosco] and externally to the mouth in case of oral breathing. The device is typically held in place with a headstrap. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 10, 2022
Effective Date
May 10, 2022
Manufacturer
Country
China
Address
No 18 Xinlian Road Xinshi Town Deqing County, Huzhou City, Zhejiang, 313201