BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    First Check

    DI: 00643281069122 · Model: 12 Drug Test · FIRST CHECK DIAGNOSTIC CORP.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    First Check
    Primary DI
    00643281069122
    Version / Model
    12 Drug Test
    Company Name
    FIRST CHECK DIAGNOSTIC CORP.
    Labeler DUNS
    945331317
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-30
    Public Version
    4
    Public Version Date
    2021-07-22
    Public Version Status
    Update
    Public Device Record Key
    a5130898-2f7a-4003-9437-bb45a8308ea3
    Distribution End Date
    2019-08-30

    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
    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
    38868 Drug-testing specimen collection kit IVD

    Identifiers

    Type ID
    Primary 00643281069122

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    40 – 86 Degrees Fahrenheit