Summary for ARTG Entry:
Fresenius Medical Care Australia Pty Ltd - Dialysis system anticoagulation solution
ARTG entry for
Medical Device Included Class IIb
Fresenius Medical Care Australia Pty Ltd
Level 17 / 61 Lavender Street,MILSONS POINT, NSW, 2061
ARTG Start Date
Medical Device Class IIb
- 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.
Fresenius Kabi AG
Bad Homburg, , D-61346
1. Dialysis system anticoagulation solution
Single Device Product
45815 Dialysis system anticoagulation solution
Sodium citrate 4% anticoagulant solution is for use only for the anticoagulation of whole blood as part of
automated apheresis procedures and continuous renal replacement therapy. This device cannot be
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:01:40 AEDT
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