BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monica

    DI: 05060433670107 · Model: 105-PT-103 · MONICA HEALTHCARE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monica
    Primary DI
    05060433670107
    Version / Model
    105-PT-103
    Company Name
    MONICA HEALTHCARE LIMITED
    Labeler DUNS
    346332666
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-12
    Public Version
    3
    Public Version Date
    2018-09-25
    Public Version Status
    Update
    Public Device Record Key
    cee2288c-0e19-447f-9364-2d01551e97b8

    Device Description

    Monica Interface CTG Cable - GE Corometrics FECG green rectangular connector

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OSP Uterine Electromyographic Monitor

    GMDN Terms

    Code Name
    43958 Foetal cardiac monitor

    Identifiers

    Type ID
    Package 15060433670104
    Primary 05060433670107