Product code NIH

Device name
Disinfectant, Subsystem, Water Purification
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5665
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Disinfectant intended for reprocessing water purification systems for hemodialysis.
Source
FDA openFDA device classification dataset