BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WROOTBOL NOTIPATCH

    DI: 08800105200150 · Model: DR-TZ+365 · ONE POWER
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    WROOTBOL NOTIPATCH
    Primary DI
    08800105200150
    Version / Model
    DR-TZ+365
    Company Name
    ONE POWER
    Labeler DUNS
    694627986
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-17
    Public Version
    1
    Public Version Date
    2021-05-25
    Public Version Status
    New
    Public Device Record Key
    43d209e8-ca39-46a6-95a9-9eec1d90dae9

    Device Description

    Thermometer, colour-indicating

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FQZ Thermometer, Clinical Color Change

    GMDN Terms

    Code Name
    35899 Colour-indication patient thermometer

    Identifiers

    Type ID
    Package 18800105200157
    Primary 08800105200150