Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
ODN · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5860
Classification
FDA Product Code
ODN
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 876.5860
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
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.