ODN

Ultrafiltration-Controlled Nocturnal Dialysate Delivery System

Product code

ODN

Device name

Ultrafiltration-Controlled Nocturnal Dialysate Delivery System

Device class

Class 2

21 CFR

21 CFR 876.5860

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).