Main information

  • Trade name:
  • Suction unit, thoracic
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Suction unit, thoracic
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221255
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Medela Australia Pty Ltd - Suction unit, thoracic

ARTG entry for

Medical Device Included Class IIb


Medela Australia Pty Ltd

Postal Address

3 Arco Lane,HEATHERTON, VIC, 3202


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- 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.




Medela AG

Lattichstrasse 4b

, Baar, 6341



1. Suction unit, thoracic

Product Type

Single Device Product

Effective date



36787 Suction unit, thoracic

Intended purpose

Intended use / indications

Thopaz+ is intended to be used for aspiration and removal of surgical fluids, tissue, gases,

bodily fluids or infectious materials. Thopaz+ is indicated for all situations where chest drains

are applied ± especially for thoracic drainage in the pleural and mediastinal cavity in situations

such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury,

pleural effusion, pleural empyema or other related conditions. Thopaz+ is intended for use

on patients in appropriate care settings.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 01:37:35 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.

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