Filter

Main information

  • Trade name:
  • Filter, gas, air, central supply system
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Filter, gas, air, central supply system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222802
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222802

Origio Australasia Pty Ltd - Filter, gas, air, central supply system

ARTG entry for

Medical Device Included Class 1

Sponsor

Origio Australasia Pty Ltd

Postal Address

31 / 7 Sefton Road,THORNLEIGH, NSW, 2120

Australia

ARTG Start Date

24/04/2014

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

Origio Inc

2400 Hunters Way

Charlottesville, Virginia, 22911

United States Of America

Products

1. Filter, gas, air, central supply system

Product Type

Single Device Product

Effective date

24/04/2014

GMDN

35069 Filter, gas, air, central supply system

Intended purpose

Designed to remove particulates and volatile organic compounds (VOCs) from the gas flowing into

incubators used in IVF procedures. The gas can be supplied through compressed air cylinders or through

gas blenders pulling air from the environment.

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 09.11.2017 at 07:49:41 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

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

27-10-2017

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