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U.S. Department of Health and Human Services

Product Classification

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Device ultrafiltration-controlled nocturnal dialysate delivery system
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.
Physical State Device is an electronic, software-controlled system with a user interface. Device can include extracorporeal tubing sets, but not necessarily.
Technical Method Device consists of a system of pumps, valves, sensors, monitors and other components that direct blood through a dialyzer so that hemodialysis may be performed.
Target Area Device is an extracorporeal device treating patients' blood.
Review Panel Gastroenterology/Urology
Product CodeODN
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type 510(k)
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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