Oxygen

Main information

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

Documents

Localization

  • Available in:
  • Oxygen cylinder regulator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221423
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221423

Rapp Australia Pty Ltd - Oxygen cylinder regulator

ARTG entry for

Medical Device Included Class IIa

Sponsor

Rapp Australia Pty Ltd

Postal Address

PO Box 120,LARA, VIC, 3212

Australia

ARTG Start Date

18/03/2014

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

Acare Technology Co Ltd

6F-6 No 5 Wuquan 1st Road

Xinzhuang District, New Taipei City,

Taiwan (Province of China)

Products

1. Oxygen cylinder regulator

Product Type

Single Device Product

Effective date

18/03/2014

GMDN

43438 Oxygen cylinder regulator

Intended purpose

A reduction valve designed to be attached via a pin indexed gastight connector to the valve stem of a

cylinder filled with oxygen, to reduce the cylinders high variable gas pressure (e.g., 50 - 250 bar) to a

lower, constant working pressure, typically 3 - 5 bar. It can be a single or a dual stage regulator, of a piston

or diaphragm design. It has a safety relief valve to avoid excessive pressure, it has a manometer to display

the available gas reserve of a gas cylinder, some models have an integrated flow control device to provide

controlled gas flow generally in the ranges of 0.25 lpm to 25 lpm to allow administration of oxygen therapy

or connection to a resuscitation bag (BVM). Some models also have a low pressure outlet/s, typically 4

bar, to allow the connection of gas driven devices such as, for example, a suction unit and/or ventilator.

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 01:07:31 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