Affinity

Main information

  • Trade name:
  • Affinity Fusion Reservoir with Oxygenator - Reservoir, blood, cardiopulmonary bypass
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Affinity Fusion Reservoir with Oxygenator - Reservoir, blood, cardiopulmonary bypass
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221965
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221965

Medtronic Australasia Pty Ltd - Affinity Fusion Reservoir with Oxygenator - Reservoir, blood,

cardiopulmonary bypass

ARTG entry for

Medical Device Included Class III

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

3/04/2014

Product category

Medical Device Class III

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

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1. Affinity Fusion Reservoir with Oxygenator - Reservoir, blood, cardiopulmonary bypass

Product Type

Medical device system

Effective date

3/04/2014

GMDN

31710 Reservoir, blood, cardiopulmonary bypass

Functional description

The Affinity Fusion Oxygenator with Integrated Arterial Filter (OXY) and Cardiotomy / Venous Reservoir is

a single-use, microporous, hollow-fiber, gas-exchange device with plasma-resistant fiber and integrated

heat exchanger, filter and reservoir.

Intended purpose

The Affinity Fusion Oxygenation System with Integrated Arterial Filter and Cardiotomy/Venous reservoir is

intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned

blood and oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during

routine cardiopulmonary bypass procedures up to 6 hours in duration. The Cardiotomy reservoir is also

intended for use during vacuum assisted venous drainage (VAVD) procedures and the Oxygenator can be

used for transfer of the volatile anesthetics isoflurane and sevoflurane by administration through the

oxygenator gas inlet by means of a suitable gas vaporizer.

Variant information

Model number (see guidance docs) CB841

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 09.11.2017 at 11:06:48 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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