BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ENVOY 500 SERUM CALIBRATOR KIT

    DI: 03661540201509 · Model: 55111 · VITALSCIENTIFIC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ENVOY 500 SERUM CALIBRATOR KIT
    Primary DI
    03661540201509
    Version / Model
    55111
    Company Name
    VITALSCIENTIFIC
    Labeler DUNS
    267732378
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2025-01-30
    Public Version Status
    Update
    Public Device Record Key
    b1167080-b246-49e6-ae95-c12eb0c42e66

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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

    GMDN Terms

    Code Name
    47868 Multiple-type clinical chemistry analyte profile IVD, calibrator

    Identifiers

    Type ID
    Primary 03661540201509