BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hemotec Whole Blood Control Kit Small

    DI: 00817869020342 · Model: WBC-HT-101 · ANALYTICAL CONTROL SYSTEMS INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Hemotec Whole Blood Control Kit Small
    Primary DI
    00817869020342
    Version / Model
    WBC-HT-101
    Company Name
    ANALYTICAL CONTROL SYSTEMS INC
    Labeler DUNS
    038232682
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-14
    Public Version
    1
    Public Version Date
    2019-11-22
    Public Version Status
    New
    Public Device Record Key
    c08b2627-0982-4596-8b6a-56f411c8e59a

    Device Description

    Whole Blood Control Kit containing 2 vials of each: SC-125, SC-126, and DW-10

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    45793 Activated clotting time (ACT) IVD, control

    Identifiers

    Type ID
    Primary 00817869020342