Extracorporeal circuit waste bag, non-sterile

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

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Fresenius Medical Care Australia Pty Ltd
Class 1
Authorization status:
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Public Summary

Summary for ARTG Entry:


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

ARTG entry for

Medical Device Included Class 1


Fresenius Medical Care Australia Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Fresenius Medical Care AG & Co KGaA

Else Kroner Strasse 1

Bad Homburg, Bad Homburg, D-61352



1. Extracorporeal circuit waste bag, non-sterile

Product Type

Single Device Product

Effective date



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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