||ultrafiltration-controlled nocturnal dialysate delivery system|
||Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.
||Device is an electronic, software-controlled system with a user interface. Device can include extracorporeal tubing sets, but not necessarily.
||Device consists of a system of pumps, valves, sensors, monitors and other components that direct blood through a dialyzer so that hemodialysis may be performed.
||Device is an extracorporeal device treating patients' blood.
Office of Device Evaluation
Division of Reproductive, Gastro-Renal, and Urological Devices
Renal Devices Branch (RNDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible