Product Classification

• 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 Code: NII
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 876.5860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 9-133 ISO 23500-1 First edition 2019-02
  Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
• 9-135 ISO 23500-3 First edition 2019-02
  Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
• 9-137 ISO 23500-5 First edition 2019-02
  Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies

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