NII

Disinfectant, Dialysate Delivery System

Product code: NII
Device name: Disinfectant, Dialysate Delivery System
Device class: Class 2
21 CFR: 21 CFR 876.5860
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 2 (all years; only the last 3 years are listed here)

FDA classification definition

Disinfectant intended for reprocessing dialysate delivery systems.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NII

Classification and pathway per current FDA publications. Data from openFDA (CC0).