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510(k) Data Aggregation

    K Number
    K233623
    Device Name
    Praxiject™ SP 0.9% NaCl
    Manufacturer
    MedXL Inc.
    Date Cleared
    2024-02-27

    (106 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedXL Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For vascular access devices flushing only. Sterile fluid path only. Not for use on a sterile field.
    Device Description
    The Praxiject™ SP 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume of 10mL with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. The Praxiject™ SP 0.9% NaCl prefilled syringe is designed to maintain a sterile fluid path only and is individually packaged in a clear flexible plastic film, flow-wrapped heatsealed pouch that functions only as a protective barrier (dust cover). The device is terminally sterilized by gamma irradiation.
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    K Number
    K231754
    Device Name
    Praxiject™ 0.9% NaCl
    Manufacturer
    MedXL Inc.
    Date Cleared
    2023-07-13

    (28 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedXL Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.
    Device Description
    The Praxiject™ family of 0.9% NaCl prefilled syringes marketed in the U.S.A. includes the following models: 37043US (3 mL/5 cc), 3704US (5 mL/5 cc), 37053US (3 mL/10 cc), 37055 US (5 mL/10 cc), 3705CUS (10 mL/10 cc), 3705-1US (10 mL/10 cc) and 3706US (20 mL/20 cc). These devices are single use plastic piston syringes with a Luer lock connection fitting, prefilled to labeled volume with 0.9% Sodium Chloride Injection USP, with no preservatives (normal saline), and capped with a plastic tip cap. Model 3705-1US (10 mL/10 cc) is individually packaged in a heat-sealed foil pouch, all other models are individually packaged in a heat-sealed peel pouch. All Praxiject™ 0.9% NaCl prefilled syringes are terminally sterilized by gamma irradiation.
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    K Number
    K192414
    Device Name
    Praxiject 0.9% NaCl
    Manufacturer
    MedXL Inc.
    Date Cleared
    2020-02-13

    (162 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedXL Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.
    Device Description
    The Praxiject™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a heat-sealed pouch and terminally sterilized by gamma irradiation.
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    K Number
    K171109
    Device Name
    Praxiject 0.9% NaCl
    Manufacturer
    MedXL Inc.
    Date Cleared
    2017-12-21

    (251 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedXL Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.
    Device Description
    The Praxiject™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled fill volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a plastic peel pouch and terminally sterilized by gamma irradiation.
    Ask a Question

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