§876.5600. Sorbent regenerated dialysate delivery system for hemodialysis. — Inbound Citations
21 C.F.R. § 876.5600
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 876.5600 as a whole
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(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).