Breathing circuit, ventilator, single use

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Getinge Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322243

Public Summary

Summary for ARTG Entry:

322243

Getinge Australia Pty Ltd - Breathing circuit, ventilator, single use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Getinge Australia Pty Ltd

Postal Address

PO Box 50,BULIMBA, QLD, 4171

Australia

ARTG Start Date

24/08/2019

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

Maquet Critical Care AB

Rontgenvagen 2

, Solna, SE-171 54

Sweden

Products

1. Breathing circuit, ventilator, single use

Product Type

Procedure Pack

Effective date

24/08/2019

GMDN

37706 Breathing circuit, ventilator, single use

Intended purpose

A breathing system with humidifier used to conduct air or oxygen-enriched gas from a ventilator to a

patient.

Specific Conditions

© 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 02.11.2019 at 06:04:38 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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