Device Dossier
Apheresis system tubing set
Device Dossier for Apheresis system tubing set (Apheresis system tubing set, Class IIa, sponsor Vantive). ARTG record, intended purpose, GMDN category —…
- GMDN category: Apheresis system tubing set
- Sponsor: Vantive
Intended purpose
The Prismaflex HP-X set is a set of bloodlines for single use, is intended to allow the integration of a blood purification device into an extracorporeal circuit. The Prismaflex HP-X set is used with the Prismaflex control unit equipped with software 7.xx or later, or with the PrisMax control unit. The Prismaflex HP-X set is indicated to patients with a body weight equal or greater than 30kg (66lb).