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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Andesfit

    DI: 00146191203803 · Model: ADF-B38A · ANDESFIT LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Andesfit
    Primary DI
    00146191203803
    Version / Model
    ADF-B38A
    Company Name
    ANDESFIT LIMITED
    Labeler DUNS
    664101036
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-15
    Public Version
    2
    Public Version Date
    2020-12-04
    Public Version Status
    Update
    Public Device Record Key
    7abf6829-38c6-4b7a-8ff4-f8ddf49ff6d5

    Device Description

    Wireless Non-Contact Infrared Body/Surface Thermometer

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FLL Thermometer, Electronic, Clinical

    GMDN Terms

    Code Name
    17888 Infrared patient thermometer, skin

    Identifiers

    Type ID
    Primary 00146191203803