Summary for ARTG Entry:
Baxter Healthcare Pty Ltd - Haemodialysis system operation software
ARTG entry for
Medical Device Included Class IIb
Baxter Healthcare Pty Ltd
PO Box 88,TOONGABBIE, NSW, 2146
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.
Gambro Lundia AB Monitor Division
Magistratsvagen 16, 10 Lund, S-220
1. Haemodialysis system operation software
Single Device Product
60638 Haemodialysis system operation software
Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the
central processing unit (CPU) incorporated into a haemodialysis system or haemodialysis system dialysate
delivery unit. This includes the software or firmware based programs and routines supplied by the
computer manufacturer that drive a specific computer in the performance of its tasks and assists the
operators, applications programmers, and programs with various supporting functions. A proprietary name
and a "version number" are commonly used to identify different operating system versions.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:48:57 AEDT
This is not an ARTG Certificate document.
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