Bowel Irrigation System Catheter

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Bosco Medical Australia
Class:
Class IIa
Authorization status:
Included
Authorization number:
323447

Public Summary

Summary for ARTG Entry:

323447

Bosco Medical Australia - Bowel Irrigation System Catheter

ARTG entry for

Medical Device Included Class IIa

Sponsor

Bosco Medical Australia

Postal Address

23/160 Lytton Road,Morningside,Brisbane, QLD, 4170

Australia

ARTG Start Date

16/09/2019

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

Hangzhou Fushan Medical Appliances Co Ltd

No 1288 Jinxi South Road Linglong Industry

Park

Zhejiang Province, Lin'an, 311301

China

Products

1. Bowel Irrigation System Catheter

Product Type

Single Device Product

Effective date

16/09/2019

GMDN

46202 Bowel Irrigation System Catheter

Intended purpose

The rectal tube is inserted via the rectum to drain waste, perform lavage and/or administer medicine to

lower intestine. The product is intended for single use only.

Specific Conditions

© 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 08.11.2019 at 10:40:21 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

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