BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TRUEplus

    DI: 00021292008178 · Model: TRUEplus Ketone Test Strips · TRIVIDIA HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    26
    Pkg Device Count
    50

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    TRUEplus
    Primary DI
    00021292008178
    Version / Model
    TRUEplus Ketone Test Strips
    Company Name
    TRIVIDIA HEALTH, INC.
    Labeler DUNS
    151810868
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2020-10-21
    Public Version
    3
    Public Version Date
    2025-08-19
    Public Version Status
    Update
    Public Device Record Key
    bd0c7872-3ba1-42d1-a4b3-7677aeebdb9e

    Device Description

    TRUEplus Ketone Test Strips

    Device Characteristics

    Single Use
    Yes
    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
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

    GMDN Terms

    Code Name
    54519 Urine ketone IVD, kit, rapid colorimetric, clinical

    Identifiers

    Type ID
    Package 00311917173900
    Primary 00021292008178
    Package 00021292001469
    Package 00041260007378
    Package 10041260007375
    Package 10021292001466
    Package 10311917173907
    Package 00719283278104
    Package 10311917203383
    Package 00311917203386
    Package 00708820514577
    Package 00311917108735
    Package 10311917108732
    Package 10050428615277
    Package 00050428615270
    Package 00050428371107
    Package 10708820514574
    Package 10021292012530
    Package 00021292012533
    Package 10011822362396
    Package 00011822362399
    Package 10050428371104
    Package 10719283278101
    Package 00050428312957
    Package 10050428312954
    Unit of Use 00021292007768

    Customer Contacts

    Phone
    +1(800)803-6025
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 86 Degrees Fahrenheit
    Type
    Special Storage Condition, Specify
    Special Conditions
    DO NOT REFRIGERATE OR FREEZE
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight