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Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

FDA product code QTI · 1 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5200
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-07-16 – 2022-07-16

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.

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