Device Dossier
Haemodialysis system operation software
Device Dossier for Haemodialysis system operation software (Haemodialysis system operation software, Class IIb, sponsor Vantive). ARTG record, intended…
- GMDN category: Haemodialysis system operation software
- Sponsor: Vantive
Intended purpose
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.