BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nuwellis, Inc.

    Reg #: 3007137787 · FEI: 3007137787 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    Nuwellis, Inc.
    Registration Number
    3007137787
    FEI Number
    3007137787
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12988 Valley View Rd
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192756

    Owner / Operator

    Firm Name
    Nuwellis, Inc.
    Operator Number
    10026935
    Address
    12988 Valley View Road
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Dawn Li

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use NQJ
    Catheter, Hemodialysis, Non-Implanted MPB
    Catheter, Hemodialysis, Implanted MSD
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Midline Catheter PND

    Proprietary Names

    Aquadex SmartFlow dELC Aquadex FlexFlow Aquadex Flexflow

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device