BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    On Call Plus Blood Glucose Test Strips

    DI: 00682607535217 · Model: G133-111 · ACON LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

    Basic Information

    Brand Name
    On Call Plus Blood Glucose Test Strips
    Primary DI
    00682607535217
    Version / Model
    G133-111
    Company Name
    ACON LABORATORIES, INC.
    Labeler DUNS
    781100966
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2022-10-31
    Public Version Status
    Update
    Public Device Record Key
    ff9dcb3c-466b-4782-bd40-a0588ea375df

    Device Description

    Blood Glucose Test Strips, box of 50 strips

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    CGA GLUCOSE OXIDASE, GLUCOSE

    GMDN Terms

    Code Name
    30854 Home-use/point-of-care blood glucose monitoring system IVD

    Identifiers

    Type ID
    Package 20682607535211
    Primary 00682607535217
    Unit of Use 00682607000173

    Customer Contacts

    Phone
    +1(800)838-9502 ext. 1
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    59 – 86 Degrees Fahrenheit