Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
The Ultrafiltration-Controlled Nocturnal Dialysate Delivery System (product code ODN) is a gastroenterology/urology device used to perform hemodialysis at night using a high-permeability hemodialyzer and an ultrafiltration-controlled system, indicated for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis). Nocturnal dialysis schedules can improve patient tolerability and clinical outcomes. This device is FDA Class 2 under regulation 876.5860 in the Gastroenterology, Urology specialty, requires 510(k) clearance, and is notably flagged as life-sustaining, reflecting its role in maintaining life for dialysis-dependent patients. It carries no implant flag.
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Basic Information
- Product Code
- ODN
- Device Class
- FDA class 2
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.