BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Blood Volume Pulse Sensor (NC-BVP-H)

    DI: 08719481550066 · Model: 1.0 · Mind Media Europe B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Blood Volume Pulse Sensor (NC-BVP-H)
    Primary DI
    08719481550066
    Version / Model
    1.0
    Company Name
    Mind Media Europe B.V.
    Labeler DUNS
    494765181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-19
    Public Version
    2
    Public Version Date
    2024-02-08
    Public Version Status
    Update
    Public Device Record Key
    4d574cdc-0c22-489a-a917-129b67f8595c

    Device Description

    NC-BVP-H (head module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    HCC Device, Biofeedback

    GMDN Terms

    Code Name
    35827 Photometer, reflectance

    Identifiers

    Type ID
    Primary 08719481550066