DeviceClearance

Product code NII— Gastroenterology, Urology

HEMOCLEAN

Classification name
Disinfectant, Dialysate Delivery System
Device class
Class 2
Regulation
21 CFR 876.5860
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Disinfectant intended for reprocessing dialysate delivery systems.”

— U.S. Food and Drug Administration, device classification record for product code NII under 21 CFR 876.5860, via openFDA

Market context for product code NII

FDA has cleared 2 devices under product code NII between 2004 and 2005, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NII

Recent clearances under product code NII

Data sourced from openFDA. This site is unofficial and independent of the FDA.