Device Dossier

Nephrology information system application software

Device Dossier for Nephrology information system application software (Nephrology information system application software, Class IIb, sponsor Vantive).…

Intended purpose

Sharesource Claria is intended to remotely communicate, monitor, and manage treatment parameters from compatible dialysis instruments used for patients undergoing Peritoneal dialysis. Sharesource Claria used for patients with renal failure prescribed peritoneal dialysis. It is used by healthcare professionals to remotely communicate, monitor, and manage new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients’ historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

TGA Public Summary