CPAP/BiPAP face mask, reusable

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

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIa
Authorization status:
Included
Authorization number:
292410

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Public Summary

Summary for ARTG Entry:

292410

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - CPAP/BiPAP face mask, reusable

ARTG entry for

Medical Device Included Class IIa

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

3/08/2017

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

BMC Medical Co

Room 110 Tower A Fengyu Building No 115

Fucheng Road Haidian

, Beijing, 100036

China

Products

1. CPAP/BiPAP face mask, reusable

Product Type

Single Device Product

Effective date

3/08/2017

GMDN

57814 CPAP/BiPAP face mask, reusable

Intended purpose

The Full Face Mask channels airflow non-invasively to a patient from a positive airway pressure device

such as a continuous positive airway pressure (CPAP) or bi-level system.

The Full Face Mask is:

· to be used by adult patients (greater than 66 lb / 30 kg) for whom positive airway pressure therapy has

been prescribed.

· intended for single-patient re-use in the home environment and multi-patient re-use in the hospital /

institutional environment.

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 01.12.2017 at 11:22:07 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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