Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5860
Review panel
GU
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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.