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0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153481

by Becton, Dickinson and Company

Identifiers

510(k) Number
K153481 FDA 510(k)
FDA Product Code
NGT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe is a sterile, single-dose, hypertonic saline solution designed for vascular access flushing. Classified as a saline flush device, it maintains patency in intravenous catheters and peripheral lines by preventing occlusion from blood or medication residues.

Supplied as a pre-filled syringe, the device is intended for single-use in clinical settings and is regulated under FDA 510(k) clearance (K153481) as a Class II medical device. It adheres to USP standards for sodium chloride injection and is intended for use in general hospital environments, with no MRI safety restrictions or reusable components.

Frequently asked questions

What is the primary purpose of the BD PosiFlush SF Syringe, and how does it differ from standard saline flushes?

The BD PosiFlush SF Syringe is designed specifically for vascular access flushing to maintain catheter or peripheral line patency by preventing occlusion from blood or medication residues. Unlike standard saline flushes, it is a pre-filled, single-dose syringe with a hypertonic 0.9% sodium chloride solution, ensuring consistent dosing and ease of use in clinical settings. Its USP-compliant formulation aligns with general saline flush standards but is optimized for reliability in high-turnover environments like hospitals.

Is this device intended for reuse, or is it strictly single-use? How should it be handled after opening?

The BD PosiFlush SF Syringe is explicitly designed for single-use only. It is sterile and pre-filled, meaning it should not be reused or shared between patients. Once opened or used, the syringe must be discarded immediately to prevent contamination and ensure patient safety. The manufacturer’s design and FDA clearance (K153481) reflect this single-use intent, aligning with best practices for sterile medical devices.

What storage conditions are recommended for the BD PosiFlush SF Syringe to maintain sterility and efficacy?

While the device data does not specify exact storage conditions, standard practice for sterile, pre-filled saline syringes like this one typically requires storage in a cool, dry place (e.g., room temperature, 20–25°C) away from direct sunlight or extreme temperatures. The packaging should remain intact until use to preserve sterility. Always check the manufacturer’s labeling for any additional storage instructions, though no MRI restrictions or special handling (like refrigeration) are indicated for this device.

Are there multiple sizes or models available for the BD PosiFlush SF Syringe, or is it a one-size-fits-all solution?

The provided data does not list specific volume sizes or model variants (e.g., 3mL, 5mL, etc.) for the BD PosiFlush SF Syringe. However, as a saline flush device, it is likely offered in common syringe sizes (e.g., 3mL or 5mL) to accommodate different vascular access needs. For exact sizing details, refer to the manufacturer’s product catalog or technical specifications, as these are not included in the regulatory submission. The device’s classification as a Class II medical device suggests it may have standardized options for clinical flexibility.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 0.9% Sodium Chloride Injection, USP 250mL - 1727170105 | BD, K231161 FDA 510 (k) - 0.9% Sodium Chloride Injection, 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K153481 24 fields · synced Oct 6, 2026