Infusion pump cassette

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

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Available from:
Abiomed Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
324256

Public Summary

Summary for ARTG Entry:

324256

Abiomed Australia Pty Ltd - Infusion pump cassette

ARTG entry for

Medical Device Included Class IIa

Sponsor

Abiomed Australia Pty Ltd

Postal Address

Level 3 1049 Victoria Road,West Ryde, NSW, 2114

Australia

ARTG Start Date

1/10/2019

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

Abiomed Inc

22 Cherry Hill Drive

MASSACHUSETTS, USA, 01923

United States Of America

Products

1. Infusion pump cassette

Product Type

Single Device Product

Effective date

1/10/2019

GMDN

57791 Infusion pump cassette

Intended purpose

Intended to be used in the Abiomed heart pump systems. It is inserted into the Abiomed Controller and

connected to an IV fluid, typically a 5% dextrose with prescribed amounts of heparin to control the flow of

fluids (purging) into the specific heart pumps.

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 02.11.2019 at 03:16:35 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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