ODN — Ultrafiltration-Controlled Nocturnal Dialysate Delivery System Class II
Classification Details
- Product Code
- ODN
- Device Class
- Class II
- Regulation Number
- 876.5860
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.