Extracorporeal circuit waste bag, non-sterile

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

Buy It Now

Available from:
Fresenius Medical Care Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
323759

Public Summary

Summary for ARTG Entry:

323759

Fresenius Medical Care Australia Pty Ltd - Extracorporeal circuit waste bag, non-sterile

ARTG entry for

Medical Device Included Class 1

Sponsor

Fresenius Medical Care Australia Pty Ltd

Postal Address

Level 17 / 61 Lavender Street,MILSONS POINT, NSW, 2061

Australia

ARTG Start Date

18/09/2019

Product category

Medical Device Class 1

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

Fresenius Medical Care AG & Co KGaA

Else Kroner Strasse 1

Bad Homburg, Bad Homburg, D-61352

Germany

Products

1. Extracorporeal circuit waste bag, non-sterile

Product Type

Single Device Product

Effective date

18/09/2019

GMDN

58868 Extracorporeal circuit waste bag, non-sterile

Intended purpose

A non-sterile flexible container intended to be used for the collection of waste fluids during preparation and

processing of an extracorporeal circuit (e.g., haemodialysis, haemofiltration, apheresis), including the

collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically

consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be

connected to the tubing system of the extracorporeal circuit. The contents are considered potentially

contaminated and should be disposed of according to local requirements. This is a single-use device.

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 10:22:30 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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