Portable

Main information

  • Trade name:
  • Portable ventilator, electric
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Portable ventilator, electric
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219898
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219898

Resmed Limited - Portable ventilator, electric

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Resmed Limited

Postal Address

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

Australia

ARTG Start Date

5/02/2014

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

Resmed Limited

1 Elizabeth Macarthur Drive

BELLA VISTA, NSW, 2153

Australia

Products

1. Portable ventilator, electric

Product Type

Single Device Product

Effective date

5/02/2014

GMDN

47083 Portable ventilator, electric

Intended purpose

An electrically-powered device providing continuous or intermittent ventilatory support for patients who

require mechanical ventilation. For use in home, hospital and portable applications for both invasive and

non-invasive ventilation.

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 06:09:29 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

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