Irrigation

Main information

  • Trade name:
  • Irrigation tubing set, general purpose
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Irrigation tubing set, general purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216830
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216830

LivaNova Australia Pty Ltd - Irrigation tubing set, general purpose

ARTG entry for

Medical Device Included Class IIa

Sponsor

LivaNova Australia Pty Ltd

Postal Address

16 - 18 Hydrive Close,South Dandenong, VIC, 3175

Australia

ARTG Start Date

1/11/2013

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

LivaNova Australia Pty Ltd

16 - 18 Hydrive Close

Dandenong South

Melbourne, VIC, 3175

Australia

Products

1. Irrigation tubing set, general purpose

Product Type

Procedure Pack

Effective date

1/11/2013

GMDN

46102 Irrigation tubing set, general purpose

Intended purpose

Collection of sterile flexible tubing & associated items that include clamps, bottle caps and connectors that

are used to deliver sterile water through a channel of a flexible endoscopes which only go through body

orifices and are used transiently. Its purpose is to irrigate the mucosal wall or the endoscope's lens to

facilitate viewing during endoscope. The water is pumped through the tubing either by a stand-alone

irrigation pump or via a pump within the endoscope's dedicated light source.

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 04:07:50 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