Suction

Main information

  • Trade name:
  • Suction system filter, smoke plume particulate
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Suction system filter, smoke plume particulate
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219966
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219966

Koala Medical Pty Ltd - Suction system filter, smoke plume particulate

ARTG entry for

Medical Device Included Class IIa

Sponsor

Koala Medical Pty Ltd

Postal Address

PO Box 1191,MONA VALE, NSW, 2103

Australia

ARTG Start Date

7/02/2014

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

Unimax Medical Systems Inc

8F-2 No 127 Lane 235 Pao Chiao Road

Hsin Tien City, Taipei,

Taiwan (Province of China)

Products

1. Suction system filter, smoke plume particulate

Product Type

Single Device Product

Effective date

7/02/2014

GMDN

31723 Suction system filter, smoke plume particulate

Intended purpose

Filtered Tube Sets intended to provide particulate filtration and/or removal of surgical smoke during

laprascopic procedures.

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 05:51:53 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.