BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HFVI SENSOR V1

    DI: 03760232460245 · Model: V1 · MDOLORIS MEDICAL SYSTEMS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HFVI SENSOR V1
    Primary DI
    03760232460245
    Version / Model
    V1
    Company Name
    MDOLORIS MEDICAL SYSTEMS
    Labeler DUNS
    262207287
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-10
    Public Version
    1
    Public Version Date
    2019-02-11
    Public Version Status
    New
    Public Device Record Key
    7b483267-6cd3-4d2f-84c3-5ed131809aa2

    Device Description

    The HFVI sensor is a disposable, pre-gelled 3-lead array. The HFVI sensor is to be usd with the HFVI Pain Monitoring System and may be worn for a continous period of 24 hours in a hospital environment.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DRX Electrode, Electrocardiograph

    GMDN Terms

    Code Name
    35035 Electrocardiographic electrode, single-use

    Identifiers

    Type ID
    Package 03760232460221
    Package 03760232460238
    Primary 03760232460245