BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Assure® Control - Control Solution Level 2 & Level 3

    DI: 00015482510060 · Model: 510006 · ARKRAY USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Assure® Control - Control Solution Level 2 & Level 3
    Primary DI
    00015482510060
    Version / Model
    510006
    Company Name
    ARKRAY USA, INC.
    Labeler DUNS
    008171162
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-26
    Public Version
    1
    Public Version Date
    2025-10-06
    Public Version Status
    New
    Public Device Record Key
    07cb4865-43d1-4464-b7ad-671126ed6c6d

    Device Description

    For use with the Assure Titanium Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. Carton contains 1 each of level 2 00015482510053 and level 3 00015482510077.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 00015482510060

    Customer Contacts

    Phone
    800-818-8877
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from direct sunlight, fluorescent light and heat. Do not freeze.
    Type
    Storage Environment Temperature
    Temperature Range
    36 – 86 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    46 – 86 Degrees Fahrenheit