BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PURE ENRICHMENT

    DI: B311PEPNGN0 · Model: PEPNGN · BEAR DOWN CONSULTING
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PURE ENRICHMENT
    Primary DI
    B311PEPNGN0
    Version / Model
    PEPNGN
    Company Name
    BEAR DOWN CONSULTING
    Labeler DUNS
    040869867
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-09
    Public Version
    1
    Public Version Date
    2020-11-17
    Public Version Status
    New
    Public Device Record Key
    763fd134-f133-4746-bb5a-3999740605f7

    Device Description

    Penguin Ear Thermometer

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    FLL Thermometer, Electronic, Clinical

    GMDN Terms

    Code Name
    17887 Infrared patient thermometer, ear

    Identifiers

    Type ID
    Package B311PEPNGN1
    Primary B311PEPNGN0