Main information

  • Trade name:
  • Suction unit, electric powered
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Suction unit, electric powered
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219615
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


KCI Medical Australia Pty Ltd - Suction unit, electric powered

ARTG entry for

Medical Device Included Class IIa


KCI Medical Australia Pty Ltd

Postal Address

PO Box 1541,LANE COVE, NSW, 1595


ARTG Start Date


Product category

Medical Device Class IIa



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.





12930 IH 10 West

San Antonio, TX, 78249

United States Of America


1. Suction unit, electric powered

Product Type

Single Device Product

Effective date



36777 Suction unit, electric powered

Intended purpose

The ABThera™ Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of

abdominal wall openings where primary closure is not possible and or repeat abdominal entries are

necessary. The Intended Use of this dressing is for use in open abdominal wounds, with exposed viscera,

including but not limited to abdominal compartment syndrome. The intended care setting is a closely

monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be

applied in the operating theater.

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 07:03:12 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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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

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