Disinfectant, Dialysate Delivery System

Device Code: 2525

Product Code(s): NII

Definition: Disinfectant Intended For Reprocessing Dialysate Delivery Systems.

Device Classification Information

• Device Type ID: 2525
• Device Name: Disinfectant, Dialysate Delivery System
• Regulation Description: High Permeability Hemodialysis System.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General Hospital
• 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)
• CFR Regulation Number: 876.5860 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NII
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 9-98 ISO 13959 Third Edition 2014-04-01
  Water For Haemodialysis And Related Therapies
• 9-99 ISO 23500 Second Edition 2014-04-01
  Guidance For The Preparation And Quality Management Of Fluids For Haemodialysis And Related Therapies
• 9-100 ISO 11663 Second Edition 2014-04-01
  Quality Of Dialysis Fluid For Haemodialysis And Related Therapies

Total Product Life Cycle

• Device Type ID: 2525
• Device: Disinfectant, Dialysate Delivery System
• Product Code: NII
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: High Permeability Hemodialysis System.
• CFR Regulation Number: 876.5860 [🔎]

TPLC Last Update: 2019-04-02 20:13:46