Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
The Saline Vascular Access Flush with Integrated Alcohol Disinfectant Device is a prefilled saline flush syringe that incorporates an integrated disinfection unit, used both to disinfect needleless access devices attached to indwelling vascular access devices (VADs) and to flush those VADs to maintain patency. The combination of disinfection and flushing functions in a single device reduces procedural steps and contamination risk. Classified as FDA Class 2 under regulation 880.5200, it requires 510(k) clearance in the General Hospital specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QTI
- Device Class
- FDA class 2
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | Jul 16, 2022 | Substantially Equivalent | Becton, Dickinson and Company |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.