Suction

Main information

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

Documents

Localization

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

Other information

Status

  • 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:

221255

Medela Australia Pty Ltd - Suction unit, thoracic

ARTG entry for

Medical Device Included Class IIb

Sponsor

Medela Australia Pty Ltd

Postal Address

3 Arco Lane,HEATHERTON, VIC, 3202

Australia

ARTG Start Date

14/03/2014

Product category

Medical Device Class IIb

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

Medela AG

Lattichstrasse 4b

, Baar, 6341

Switzerland

Products

1. Suction unit, thoracic

Product Type

Single Device Product

Effective date

14/03/2014

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information

16-10-2018

Abond Group Inc. recalls Tubeez Baby Bath Support

Abond Group Inc. recalls Tubeez Baby Bath Support

The bath support’s suction cups may not adhere to the bath surface, making it unstable and cause it to possibly tip over while in use. In addition, an infant can slip underneath the front support bar and become lodged under water posing a drowning hazard.

Health Canada

There are no news related to this product.