Product code NHV

Device name
System, Water Purification, General Medical Use
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5665
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.
Source
FDA openFDA device classification dataset