21 CFR 876.5600 - Sorbent regenerated dialysate delivery system for hemodialysis.

§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.

(a)Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories ( § 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.

(b)Classification. Class II (performance standards).

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United States Code

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 876 after this date.

  • 2018-06-15; vol. 83 # 116 - Friday, June 15, 2018
    1. 83 FR 27895 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective June 15, 2018. The classification was applicable on December 21, 2017.
      21 CFR Part 876
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