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    K Number
    K252040

    Validate with FDA (Live)

    Device Name
    BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2026-03-13

    (256 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    K945952,K944566
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K945952, K944566

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    • BD Vacutainer® Plasma Separator Tubes (PST™)

    The BD Vacutainer® Plasma Separator Tubes (PST™) are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by healthcare professionals for the collection, containment, and transport of human venous blood specimens, and the subsequent separation and storage of plasma for in vitro diagnostic testing.

    BD Vacutainer® Plasma Separator Tubes (PST™) are used for testing chemistry analytes in plasma samples.

    • BD Vacutainer® Sodium Heparin Blood Collection Tubes

    The BD Vacutainer® Sodium Heparin Blood Collection Tube is a sterile, single-use, in vitro diagnostic medical device for the collection, containment, transport of human venous blood specimens, and the subsequent separation of plasma by centrifugation, for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a healthcare professional.

    The BD Vacutainer® Sodium Heparin Blood Collection Tube is used for testing lithium.

    Device Description

    BD Vacutainer® Plasma Separator Tubes (PST™) and BD Vacutainer® Sodium Heparin Blood Collection Tubes are sterile Blood Collection Tubes which use a controlled vacuum to pull a specific volume of blood into the tube. Each BD Vacutainer® Plasma Separator Tube (PST™) and BD Vacutainer® Sodium Heparin Blood Collection Tube consists of 1) a plastic tube manufactured from PET (polyethylene terephthalate), 2) a BD Hemogard™ cap assembly or Conventional rubber stopper with lubricant, and 3) a spray-dried anti-coagulated formulated from lithium or sodium heparin. The BD Vacutainer® Plasma Separator Tubes (PST™) additionally include an inert polymer separator gel.

    AI/ML Overview

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