0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
by Becton, Dickinson and Company
510(k) K213955
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213955 | Date16 Jul 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QTI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device is a sterile, prefilled syringe containing 0.9% sodium chloride injection, USP, combined with an integrated alcohol disinfectant unit. It is designed to flush vascular access ports while providing simultaneous disinfection of the insertion site, reducing the risk of infection during intravenous procedures.
This device is supplied as a single-use, prefilled syringe intended for use in general hospital settings. It is non-PVC, non-DEHP, and not made with natural rubber latex, ensuring compatibility with sensitive patient populations. The device is cleared by the FDA under 510K clearance (K213955) as substantially equivalent to existing saline flush systems, adhering to regulatory standards for vascular access maintenance.
From the manufacturer
Overview Discover a dependable solution for IV fluids BD ® offers a family of IV fluids to suit customer needs. All IV fluids use the freeflex ® bag, a multilayer polyolefin film that is non-PVC and non-DEHP and not made with natural rubber latex.
Combined clinically-proven technologies The clinically-demonstrated technology of the BD PosiFlush™ Prefilled Saline Syringe and BD Site-Scrub™ Isopropyl Alcohol (IPA) Device combined to create an innovative, all-in-one active scrub and flush solution—the PosiFlush™ SafeScrub Prefilled Saline Flush Syringe.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the BD PosiFlush SafeScrub device in clinical settings?
The BD PosiFlush SafeScrub is designed to flush vascular access ports while simultaneously disinfecting the insertion site with an integrated alcohol disinfectant. This dual-action feature helps reduce the risk of infection during intravenous procedures, making it ideal for maintaining clean vascular access in hospital environments.
Is this device safe for patients with latex sensitivities or those requiring non-PVC materials?
Yes, the BD PosiFlush SafeScrub is manufactured without natural rubber latex and is non-PVC, ensuring compatibility with sensitive patient populations who may have allergies or sensitivities to these materials.
How is the BD PosiFlush SafeScrub supplied, and is it reusable?
The device is supplied as a single-use, prefilled syringe, meaning each unit is intended for one-time use only. This design ensures sterility and safety for each procedure, eliminating the need for reuse or reprocessing.
What types of hospitals or clinical settings is this device intended for?
The device is cleared for use in general hospital settings, specifically for vascular access maintenance. Its design aligns with standard practices in hospitals where intravenous procedures are performed regularly.
How should the BD PosiFlush SafeScrub be stored to maintain its integrity?
Since it is a sterile, prefilled syringe, it should be stored in a clean, dry place away from direct sunlight and extreme temperatures. Proper storage ensures the device remains uncontaminated and ready for single-use applications as intended.