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U.S. Department of Health and Human Services

Product Classification

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Device disinfectant, dialysate delivery system
Regulation Description High permeability hemodialysis system.
Definition Disinfectant intended for reprocessing dialysate delivery systems.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General Hospital
Product CodeNII
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 876.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA
Third Party Review Not Third Party Eligible
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