BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Assure® Prism Control Solution

    DI: 00015482530068 · Model: 530006 · ARKRAY USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Assure® Prism Control Solution
    Primary DI
    00015482530068
    Version / Model
    530006
    Company Name
    ARKRAY USA, INC.
    Labeler DUNS
    008171162
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-22
    Public Version
    1
    Public Version Date
    2019-02-22
    Public Version Status
    New
    Public Device Record Key
    ad4cf8be-0617-4863-8db5-e8e6ad9b86e6

    Device Description

    Assure Prism Control Solution contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482530068 is used as the assigned UDI for the Class I device.)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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 00015482530068

    Customer Contacts

    Phone
    800-818-8877
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    46 – 86 Degrees Fahrenheit