21 CFR 876.5830 — Dialyzer, Disposable

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5830

Identification

A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that includes disposable inserts consisting of layers of semipermeable membranes which are sandwiched between support plates. The device is used with the extracorporeal blood system and the dialysate delivery system of the hemodialysis system and accessories (§ 876.5820).

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
FJHDialyzer, Disposable24Life-Sustaining
Innolitics

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