Filter

Main information

  • Trade name:
  • Filter, humidifier, heat/moisture exchanger
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Filter, humidifier, heat/moisture exchanger
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219448
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219448

Resmed Limited - Filter, humidifier, heat/moisture exchanger

ARTG entry for

Medical Device Included Class IIa

Sponsor

Resmed Limited

Postal Address

Regulatory Affairs / 1 Elizabeth Macarthur Drive,BELLA VISTA, NSW, 2153

Australia

ARTG Start Date

22/01/2014

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

GVS Filter Technology UK - Medical Air

Filtration Division

NFC House Vickers Industrial Estate Mellishaw

Lane Morecambe

Lancs, , LA3 3EN

Products

1. Filter, humidifier, heat/moisture exchanger

Product Type

Single Device Product

Effective date

22/01/2014

GMDN

37597 Filter, humidifier, heat/moisture exchanger

Intended purpose

Single-use device to be used to heat and humidify air and other respiratory gases inspired by 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 07:31:22 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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