Mask, non-rebreathing, aerosol

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Australian Medical Consumables Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
292193

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Public Summary

Summary for ARTG Entry:

292193

Australian Medical Consumables Pty Ltd - Mask, non-rebreathing, aerosol

ARTG entry for

Medical Device Included Class IIa

Sponsor

Australian Medical Consumables Pty Ltd

Postal Address

PO Box 864,Cleveland, QLD, 4163

Australia

ARTG Start Date

28/07/2017

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Yiles Medical Co Ltd

Chuangye Road 1199 Jinxian Nanchang City

, Jiangxi, 331700

China

Products

1. Mask, non-rebreathing, aerosol

Product Type

Single Device Product

Effective date

28/07/2017

GMDN

35172 Mask, non-rebreathing, aerosol

Intended purpose

A mask that is placed over the patient's nose and mouth intended to deliver air, oxygen or a mixture of the

two gases containing aerosol particles to the patient's airway.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 03.11.2017 at 09:58:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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