ODN
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| NxStage System One (K150472) | Nxstage Medical, Inc. | 2015-06-04 | + Add |
| NXSTAGE SYSTEM ONE (K141752) | Nxstage Medical, Inc. | 2014-12-19 | + Add |
Track ODN automatically
Every clearance here is in the API, with alerts when new ones post.