BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VU

    DI: 00860009142923 · Model: WS-MAT-200-06 · Wellsense, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VU
    Primary DI
    00860009142923
    Version / Model
    WS-MAT-200-06
    Company Name
    Wellsense, Inc.
    Labeler DUNS
    080403189
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-09
    Public Version
    1
    Public Version Date
    2024-04-17
    Public Version Status
    New
    Public Device Record Key
    29dfae5c-a771-4767-9f8d-ecd55b4394e5

    Device Description

    The VU system provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure which substantially reduces the risk of pressure injuries. This variant for narrow format hospital beds.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JFC System, Pressure Measurement, Intermittent

    GMDN Terms

    Code Name
    43829 Body-surface pressure mapping system

    Identifiers

    Type ID
    Primary 00860009142923