Oxygen

Main information

  • Trade name:
  • Oxygen concentrator
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Oxygen concentrator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216698
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216698

Ausmedi International Pty Ltd - Oxygen concentrator

ARTG entry for

Medical Device Included Class IIa

Sponsor

Ausmedi International Pty Ltd

Postal Address

6 / 3-4 Anzed Court,MULGRAVE, VIC, 3170

Australia

ARTG Start Date

30/10/2013

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

Meditech Technology Co Ltd

1001 10/F/Tower B Yinyuan Garden 22

Minsheng Avenue Jinan City

Shandong Province, , 250001

China

Products

1. Oxygen concentrator

Product Type

Single Device Product

Effective date

30/10/2013

GMDN

12873 Stationary oxygen concentrator

Intended purpose

Our oxygen generator produces oxygen according to the theory of pressure swing adsorption .The oxygen

generator is available to be used in central oxygen supply system.The oxygen purity can reach

93%±3%.The oxygen therapy equipment can be used in oxygen therapy center,hospitals and veterinary

clinic,etc.

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 04:31:46 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

There are no safety alerts related to this product.

10-8-2018

Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery  https://go.usa.gov/xUHgr  #fda #medicaldevice

Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery https://go.usa.gov/xUHgr  #fda #medicaldevice

Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery https://go.usa.gov/xUHgr  #fda #medicaldevice

FDA - U.S. Food and Drug Administration