QTI

Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

Product code

QTI

Device name

Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

Device class

Class 2

21 CFR

21 CFR 880.5200

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).