BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Advocate Control Solutions Low

    DI: 00894046001585 · Model: 003 · DIABETIC SUPPLY OF SUNCOAST, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Advocate Control Solutions Low
    Primary DI
    00894046001585
    Version / Model
    003
    Catalog Number
    BMB003
    Company Name
    DIABETIC SUPPLY OF SUNCOAST, INC.
    Labeler DUNS
    043081723
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-19
    Public Version
    5
    Public Version Date
    2020-09-02
    Public Version Status
    Update
    Public Device Record Key
    4213e192-00b3-4793-9359-dd7f83ea964a

    Device Description

    Advocate Control Solutions Level 1 Low 4 ml Bottle

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

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 00894046001585
    Package 20894046001589

    Customer Contacts

    Phone
    1-888-469-3579
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    0 – 85 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    0 – 85 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    39.2 – 104 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    4 – 40 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    50 – 104 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius