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510(k) Data Aggregation

    K Number
    K250884

    Validate with FDA (Live)

    Device Name
    0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2025-12-02

    (253 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K161552
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices.

    Device Description

    BD PosiFlush™ SP Syringe is a three-piece, single use syringe with a Luer connector that is compatible with ISO 80369-7:2021 small-bore connectors for liquids and gases in healthcare applications- Part 7: Connectors for intravascular or hypodermic applications. The syringe is prefilled with 0.9% sodium chloride injection, USP and sealed with a tip cap. PosiFlush SP Syringe is individually packaged inside a flow wrap. The moist heat sterilization process renders the syringe a Sterility Assurance Level of 10⁻⁶ for the fluid path and saline solution.

    AI/ML Overview

    N/A

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