Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
ODN is the FDA product code for Ultrafiltration-Controlled Nocturnal Dialysate Delivery System, a class II device type, regulated under 21 CFR 876.5860. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- ODN
- Device name
- Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
- FDA 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.
- Regulation
- 21 CFR 876.5860
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code ODN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
Applicants with the most clearances
Product code ODN| Applicant | Clearances |
|---|---|
| NxStage Medical Inc | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code ODN.
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