21 CFR 876.5600
§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.5600, § 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90351
- Permanent ID
ys:prov:90351@1- SHA-256
3610c1fd6edfc9f40f421b6fac35861aef241487a1f009126543bcc5066e4e1c
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.