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:
  • 219980
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219980

BOC Limited - Oxygen concentrator

ARTG entry for

Medical Device Included Class IIa

Sponsor

BOC Limited

Postal Address

PO Box 288,CHATSWOOD, NSW, 2057

Australia

ARTG Start Date

7/02/2014

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

Inogen Inc

326 Bollay Drive

Goleta, California, 93117

United States Of America

Products

1. Oxygen concentrator

Product Type

Medical device system

Effective date

7/02/2014

GMDN

12873 Stationary oxygen concentrator

Intended purpose

The Oxygen Concentrator device is used by patients requiring supplemental oxygen. The device supplies

a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator

to the patient.

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 05:48:13 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