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510(k) Data Aggregation

    K Number
    K220458
    Device Name
    UltraFlo-R Push Button Blood Collection Set
    Manufacturer
    Innovative Medical Technologies, Inc.
    Date Cleared
    2023-09-29

    (589 days)

    Product Code
    JKA, FPA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Innovative Medical Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultraflo-R Push Button Blood Collection Set is a sterile, single-use, winged blood collection set intended for vempuncture to obtain blood specimens from patients. The device is connected to a syringe or evacuated blood collection tube for collection of the specimen. The Ultraflo-R Push Button Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for patient populations over 2500 grams with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. After completion of the blood draw or infusion, the recommended use of the device is to depress the button on the top of the device to activate needle retraction into the device prior to removal from the venipuncture site. This is a one-handed activation of the safety feature. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needle-stick injury. The device is not used for a diagnostic or treatment purpose.
    Device Description
    Not Found
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    K Number
    K123987
    Device Name
    IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2013-08-27

    (244 days)

    Product Code
    JKA, FMI
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non- patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter. The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient's vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male luer adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device.
    Device Description
    Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter. The Improsafe Blood Collection Set includes an attached safety shield.
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    K Number
    K972969
    Device Name
    QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-09-22

    (42 days)

    Product Code
    GIO, JKA
    Regulation Number
    864.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.
    Device Description
    The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.
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