0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe, SF Syringe
by Becton, Dickinson and Company
510(k) K141311
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141311 | Date25 Jul 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NGT
- Models / Variants
- 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 0.9% Sodium Chloride Injection, USP BD PosiFlush is a sterile, nonpyrogenic solution designed as a saline flush for vascular access devices. It provides isotonic hydration to maintain patency of indwelling catheters, ports, or lines by clearing residual medications, blood, or clots.
Supplied as prefilled SP Syringe and SF Syringe configurations, the device is intended for single-use in clinical settings such as general hospitals. Sterility is maintained via terminal sterilization, and the product complies with FDA 510(k) clearance (K141311) under product code NGT, classified as a Class II device under regulation 880.5200. No MRI safety labeling is specified.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the 0.9% Sodium Chloride Injection, USP BD PosiFlush, and how does it differ from regular saline flushes?
The 0.9% Sodium Chloride Injection, USP BD PosiFlush is specifically designed as a sterile, nonpyrogenic saline flush to maintain the patency of vascular access devices like indwelling catheters, ports, or lines. Unlike generic saline flushes, it is formulated to clear residual medications, blood, or clots from these devices, ensuring they remain clear and functional for continued use in clinical settings such as general hospitals. Its isotonic nature helps provide hydration while preventing irritation or damage to the vascular access.
Are the SP Syringe and SF Syringe configurations of BD PosiFlush interchangeable, or do they serve different purposes?
The SP Syringe and SF Syringe configurations of BD PosiFlush are both prefilled saline flushes, but they are likely designed for different syringe types or clinical workflows. While the exact differences between SP and SF are not specified, the distinction may relate to syringe size, plunger design, or compatibility with specific vascular access devices. Always verify compatibility with your facility’s protocols or the device’s labeling to ensure proper use.
How should I store BD PosiFlush to ensure its sterility and effectiveness, and is it meant for single-use only?
BD PosiFlush is terminally sterilized, so it should be stored in a clean, dry place away from direct sunlight and extreme temperatures, following the manufacturer’s recommended storage conditions (typically 20–25°C/68–77°F). The device is explicitly intended for single-use only in clinical settings, as indicated by its design and sterile packaging. Reusing it could compromise sterility and patient safety.
Does BD PosiFlush have any special considerations for use in patients who require frequent vascular access procedures?
Yes, BD PosiFlush is ideal for patients requiring frequent vascular access procedures, such as those with indwelling catheters, ports, or lines. Its isotonic formulation helps maintain catheter patency by flushing out residual blood, medications, or clots, reducing the risk of occlusion. However, always follow your facility’s protocols for flushing frequency and technique to ensure optimal device function and patient safety.