BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Set of electrodes

    DI: 09120073930460 · Model: V1.0 · CNSystems Medizintechnik AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Set of electrodes
    Primary DI
    09120073930460
    Version / Model
    V1.0
    Catalog Number
    01616
    Company Name
    CNSystems Medizintechnik AG
    Labeler DUNS
    303562672
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-27
    Public Version
    4
    Public Version Date
    2019-11-20
    Public Version Status
    Update
    Public Device Record Key
    d0a553fc-5fe8-490d-b38d-b4b4be4e9f03
    Distribution End Date
    2019-11-19

    Device Description

    Set of 4ECG electrodes, 3 ICG electrodes and one grounding pad

    Device Characteristics

    Single Use
    Yes
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    61237 Noninvasive haemodynamic monitoring system

    Identifiers

    Type ID
    Primary 09120073930460
    Package 09120073930477
    Package 09120073930484

    Customer Contacts

    Phone
    +4331672345633
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K014063 000