DeviceClearance

Product code QTI— General Hospital

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

Classification name
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
Device class
Class 2
Regulation
21 CFR 880.5200
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QTI under 21 CFR 880.5200, via openFDA

Market context for product code QTI

FDA has cleared 1 device under product code QTI, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QTI

Recent clearances under product code QTI

Data sourced from openFDA. This site is unofficial and independent of the FDA.