Device Dossier

Water purification unit, filter, particulate

Device Dossier for Water purification unit, filter, particulate (Water purification unit, filter, particulate, Class IIa, sponsor Fresenius Medical…

Intended purpose

The Purification Pack (PAK) filters and purifies water. It removes organic components such as Bacteria and endotoxins. It also removes inorganic contaminants’ such as metals and salts. This is used as a component with the NxStage Pureflow SL which prepares AAMI (Association for the Advancement of Medical Instrumentation) quality dialysate for the use during haemodialysis.

TGA Public Summary