Mask

Main information

  • Trade name:
  • Mask, non-rebreathing, air/oxygen
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Mask, non-rebreathing, air/oxygen
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216605
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216605

Thermo Fisher Scientific Australia Pty Ltd - Mask, non-rebreathing, air/oxygen

ARTG entry for

Medical Device Included Class IIa

Sponsor

Thermo Fisher Scientific Australia Pty Ltd

Postal Address

PO Box 9092,SCORESBY, VIC, 3179

Australia

ARTG Start Date

26/10/2013

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

Unomedical Inc

5701-1 South Ware Road

McAllen, TX, 78503

United States Of America

Products

1. Mask, non-rebreathing, air/oxygen

Product Type

Single Device Product

Effective date

26/10/2013

GMDN

35173 Mask, non-rebreathing, air/oxygen

Intended purpose

Mask placed over the patient's mouth and nose and connected directly to a compressed air or oxygen

supply, to deliver high concentration oxygen to the patient's airways assuring minimal rebreathing of

exhalation gas.

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 10.11.2017 at 04:44:49 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

18-7-2018

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

11-5-2018

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in its product design that may result in difficultly or the inability to disconnect the mask from the elbow of the resuscitator.

FDA - U.S. Food and Drug Administration

There are no news related to this product.