BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3CPM Company, Inc

    DI: 00864359000216 · Model: 2.09e · 3CPM CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3CPM Company, Inc
    Primary DI
    00864359000216
    Version / Model
    2.09e
    Company Name
    3CPM CO., INC.
    Labeler DUNS
    022772521
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-27
    Public Version
    5
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    00591be2-b35e-4b62-8066-727e579f35c0

    Device Description

    3CPM Company Electrogastrogram Research platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.

    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
    Yes
    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
    MYE System,Electrogastrography(Egg)

    GMDN Terms

    Code Name
    64488 Myoelectric gastrointestinal motility analysis system

    Identifiers

    Type ID
    Primary 00864359000216

    Premarket Submissions

    Submission Number Supplement Number
    DEN990005 000