BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Revi™ Wearable Device

    DI: 07290017912042 · Model: MA-3000-1300 · BLUEWIND MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Revi™ Wearable Device
    Primary DI
    07290017912042
    Version / Model
    MA-3000-1300
    Company Name
    BLUEWIND MEDICAL LTD
    Labeler DUNS
    534159913
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-28
    Public Version
    1
    Public Version Date
    2026-02-05
    Public Version Status
    New
    Public Device Record Key
    7817f865-5e45-4d69-b9b1-2ce02738466c

    Device Description

    Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters.

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    QXM Implanted Tibial Electrical Urinary Continence Device

    GMDN Terms

    Code Name
    64780 Tibial nerve implantable incontinence-control electrical stimulation system

    Identifiers

    Type ID
    Primary 07290017912042

    Customer Contacts

    Phone
    18887152080
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    DEN220073 000
    K240037 000
    K252391 000