[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5600]

[Page 370]
 
                        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 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).