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Ultrafiltration-Controlled Nocturnal Dialysate Delivery System

Ultrafiltration-Controlled Nocturnal Dialysate Delivery System is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Gastroenterology, Urology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

ODN

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Class 2

21 CFR 876.5860

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Gastroenterology, Urology

Device Characteristics

No

No

Yes

Not Eligible

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.