Summary for ARTG Entry:
Getinge Australia Pty Ltd - Tubing Set with Bioline Coating without oxygenator - Tubing set, heart-lung
ARTG entry for
Medical Device Included Class III
Getinge Australia Pty Ltd
PO Box 50,BULIMBA, QLD, 4171
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.
Maquet Cardiopulmonary AG
38 Hechinger Strasse
Hirrlingen, Hirrlingen, D72145
1. Tubing Set with Bioline Coating without oxygenator - Tubing set, heart-lung bypass
Single Device Product
35441 Cardiopulmonary bypass system tubing set
The Bioline coated tubing sets are designed to be used for transportation of blood and other liquids
between the patient and the extracorporeal system.
Maquet's Bioline coated tubing sets consisting of tubing, connectors, filters and various other items are
designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures.
Model number (see guidance docs) BE-H 46343
Diameter (mm) 1.6 -16
Model number (see guidance docs) BE-H 89500
Model number (see guidance docs) BE-H 46338
Model number (see guidance docs) BE-H 46334
Model number (see guidance docs) BE-H 46305
Model number (see guidance docs) BE-H 46302
Model number (see guidance docs) BE-H 100200
Model number (see guidance docs) BE-H 87420
No Specific Conditions included on Record
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Produced at 09.11.2017 at 11:34:18 AEDT
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