Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
Medical specialty
General Hospital
Device class
2
Regulation number
880.5200
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Prefilled saline flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.