Summary for ARTG Entry:
Terumo Australia Pty Ltd - Tubing set, heart-lung bypass
ARTG entry for
Medical Device Included Class IIa
Terumo Australia Pty Ltd
PO Box 312,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class IIa
- 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.
Terumo Europe NV
, Leuven, 3001
1. Tubing set, heart-lung bypass
Single Device Product
35441 Cardiopulmonary bypass system tubing set
A pre-packaged sterile tubing set containing tubing and other items (such as clamps, filters, connectors,
oxygenator, reservoir, haemoconcentrator, heat exchanger) used in the extracorporeal circuit during
cardiopulmonary (heart-lung) bypass procedures for up to 6 hours
No Specific Conditions included on Record
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Produced at 10.11.2017 at 02:25:58 AEDT
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