Insufflator

Main information

  • Trade name:
  • Insufflator, endoscopic
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Insufflator, endoscopic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217272
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217272

Cantel (Australia) Pty Ltd - Insufflator, endoscopic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Cantel (Australia) Pty Ltd

Postal Address

Level 3 24-26 Albert Road,South Melbourne, VIC, 3205

Australia

ARTG Start Date

13/11/2013

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

Medivators Inc

3150 Pollok Drive

Conroe, TX, 77303

United States Of America

Products

1. Insufflator, endoscopic

Product Type

Single Device Product

Effective date

13/11/2013

GMDN

36750 Insufflator, endoscopic

Intended purpose

To deliver CO2 through an endoscope in order to prevent dew/mist from accumulating at the lens and/or

enlarge the space directly forward of the distal end to obtain a better field of view for the operator.

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 02:42:52 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