BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AEM® Monitor

    DI: 10815288014147 · Model: EM3+ · ENCISION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AEM® Monitor
    Primary DI
    10815288014147
    Version / Model
    EM3+
    Catalog Number
    EM3+
    Company Name
    ENCISION, INC.
    Labeler DUNS
    612250175
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-04
    Public Version
    1
    Public Version Date
    2022-02-14
    Public Version Status
    New
    Public Device Record Key
    b1e45245-aade-4d42-b1c2-d2e209dfe7d4

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    36152 Electrosurgical system monitor/shield

    Identifiers

    Type ID
    Primary 10815288014147

    Premarket Submissions

    Submission Number Supplement Number
    K122383 000