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510(k) Data Aggregation

    K Number
    K213015
    Device Name
    DORA Disposable A.V. Fistula Needle Sets
    Manufacturer
    Bain Medical Equipment (Guangzhou)Co., Ltd.
    Date Cleared
    2022-04-08

    (200 days)

    Product Code
    FIE
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bain Medical Equipment (Guangzhou)Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DORA Disposable A.V. Fistula Needle Sets (Safety Needle Series) are sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield is used for protecting from needlestick imiury. The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. The DORA Disposable A.V. Fistula Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.
    Device Description
    The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of flexible tube and sharp needle. It is available in three types, 1) Needle sets with safety feature, 2) Needle sets without safety feature and 3 > Dull Needle sets. Both the three types of proposed device are provided sterile and are for single use only. The three types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing). The proposed device and its package are designed to be provided in Ebeam sterilization. The package could maintain the sterility of the device for three years. The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.
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