BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Whole Blood Control Level III

    DI: 00817869020274 · Model: SC-127 · ANALYTICAL CONTROL SYSTEMS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Whole Blood Control Level III
    Primary DI
    00817869020274
    Version / Model
    SC-127
    Catalog Number
    SC-127
    Company Name
    ANALYTICAL CONTROL SYSTEMS INC
    Labeler DUNS
    038232682
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-31
    Public Version
    1
    Public Version Date
    2019-03-04
    Public Version Status
    New
    Public Device Record Key
    98cbe118-69af-40d3-bbb8-a5e5c8a1f45a

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JPA System, Multipurpose For In Vitro Coagulation Studies

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00817869020274

    Premarket Submissions

    Submission Number Supplement Number
    K925340 000