BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DANFLOW Wave CU

    DI: 08594211570138 · Model: FU1101 · MEDKONSULT medical technology s.r.o.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DANFLOW Wave CU
    Primary DI
    08594211570138
    Version / Model
    FU1101
    Catalog Number
    FU1101
    Company Name
    MEDKONSULT medical technology s.r.o.
    Labeler DUNS
    361814147
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-27
    Public Version
    1
    Public Version Date
    2022-06-06
    Public Version Status
    New
    Public Device Record Key
    3f8113ed-6435-4cdb-8b5a-8d9decec1963

    Device Description

    The DANFLOW Wave CU is one of MMT's (MEDKONSULT medical technology s.r.o.) Urodynamic family of medical devices. The DANFLOW Wave CU (FU1101) is a small standalone wireless urodynamic measuring system for uroflowmetry.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    Yes
    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
    Yes
    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

    GMDN Terms

    Code Name
    14307 Urodynamic measurement system

    Identifiers

    Type ID
    Primary 08594211570138