Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Affinity Fusion Reservoir with Oxygenator - Reservoir, blood,
ARTG entry for
Medical Device Included Class III
Medtronic Australasia Pty Ltd
PO Box 945,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class III
- 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.
710 Medtronic Parkway
Minneapolis, MN, 55432
United States Of America
1. Affinity Fusion Reservoir with Oxygenator - Reservoir, blood, cardiopulmonary bypass
Medical device system
31710 Reservoir, blood, cardiopulmonary bypass
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.
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.
Model number (see guidance docs) CB841
No Specific Conditions included on Record
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