ODNClass IILife-sustaining
Ultrafiltration-controlled Nocturnal Dialysate Delivery System
Gastroenterology, Urology · 21 CFR 876.5860
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.
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances2All time
Recent MDR events
0 adverse event reports on file
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Event type breakdown
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Most-reported manufacturers
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
2 clearances for this product code