DeviceClearance

Product code NIH— Gastroenterology, Urology

MINNCARE HD

Classification name
Disinfectant, Subsystem, Water Purification
Device class
Class 2
Regulation
21 CFR 876.5665
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Disinfectant intended for reprocessing water purification systems for hemodialysis.”

— U.S. Food and Drug Administration, device classification record for product code NIH under 21 CFR 876.5665, via openFDA

Market context for product code NIH

FDA has cleared 1 device under product code NIH, all in 2014, filed by 1 applicant company. 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.

Top applicants under product code NIH

Recent clearances under product code NIH

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