QTI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Medical specialty
- General Hospital
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub (K213955) | Becton, Dickinson and Company | 2022-07-16 | + Add |
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