Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K172957
    Device Name
    Kawasumi Laboratories Blood Drawing Kit (BDK) System
    Manufacturer
    Kawasumi Laboratories, Inc.
    Date Cleared
    2018-09-28

    (367 days)

    Product Code
    KSB, FMI, LHI
    Regulation Number
    864.9875
    Why did this record match?
    Product Code :

    KSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.
    Device Description
    The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. The device is not intended for blood transfusion. The Kawasumi Laboratories Blood Drawing Kit (BDK) System consists of a Blood Drawing Kit device that is designed with an integral Antineedle Stick Protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein and may incorporate a needleless access connector site used for blood sampling. The Blood Drawing Kit System is a single use, disposable Ethylene Oxide Sterilized medical device. The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a sterile, single-use device that consists of the following components: Needle Protector, Cannula, Hub, Wing, Antineedle Stick Protector "K-Shield", Tubing, Needleless Access Connector (NAC) Y-Site, Clamp, Blood Bag Unit Reservoir.
    Ask a Question
    K Number
    K001043
    Device Name
    KAWASUMI LABORATORY BLOOD DRAWING KIT
    Manufacturer
    KAWASUMI LABORATORIES AMERICA, INC.
    Date Cleared
    2000-05-19

    (49 days)

    Product Code
    KSB
    Regulation Number
    864.9875
    Why did this record match?
    Product Code :

    KSB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1