[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5600]

[Page 356-357]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                     Subpart F--Therapeutic Devices
 
Sec. 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

[[Page 357]]

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 (Sec. 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).