Mask

Main information

  • Trade name:
  • Mask, aerosol
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Mask, aerosol
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216521
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216521

Medical Developments International Limited - Mask, aerosol

ARTG entry for

Medical Device Included Class 1

Sponsor

Medical Developments International Limited

Postal Address

PO Box 9004,Scoresby, VIC, 3179

Australia

ARTG Start Date

24/10/2013

Product category

Medical Device Class 1

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

Foremount Enterprise Co Ltd

17 Alley 15 Lane 5 Shenan Street

Shengang Hsiang Taichung County, Taiwan,

42944

Taiwan (Province of China)

Products

1. Mask, aerosol

Product Type

Single Device Product

Effective date

24/10/2013

GMDN

35142 Aerosol face mask, rebreathing

Intended purpose

A silicone face mask placed over the nose and mouth used in combination with a pressurized metered

dose inhaler and a space chamber to assist in the delivery of aerosolized medication. It is available in a

range of sizes and is single patient use.

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 04:59:48 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.