BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)

    DI: 00057565166191 · Model: 016-619 · A.M.G. Médicale Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)
    Primary DI
    00057565166191
    Version / Model
    016-619
    Catalog Number
    016-619
    Company Name
    A.M.G. Médicale Inc
    Labeler DUNS
    207372814
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-09
    Public Version
    2
    Public Version Date
    2025-12-15
    Public Version Status
    Update
    Public Device Record Key
    7f5428ba-3557-4170-a732-56c624e5c47d

    Device Description

    DigiPro+ ™ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. What’s more, DigiPro+™ utilizes a “real measurement” technology, which permits read after the beep if a higher temperature is later detected. Accurate within ± 0.1°C in the 35.5°C to 42°C range Displays in Celsius or Fahrenheit Response time: 30 seconds for oral readings Auto shut-off feature Memory recall / display of last reading Individually packaged, includes storage case

    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
    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
    14035 Intermittent electronic patient thermometer

    Identifiers

    Type ID
    Package 00057565975120
    Primary 00057565166191
    Package 00057565975137