BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ivWatch Model 400

    Reg #: 3011490091 · FEI: 3011490091 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IVWATCH, LLC
    Registration Number
    3011490091
    FEI Number
    3011490091
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    700 Tech Center Parkway, Suite 300
    City
    Newport News
    State
    VA
    ZIP
    23606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162478

    Owner / Operator

    Firm Name
    ivWatch, LLC
    Operator Number
    10048801
    Address
    700 Tech Center Parkway, Suite 300
    City
    Newport News
    State
    VA
    Postal Code
    23606
    Country
    US
    Correspondent
    Holly Novak

    Products

    Device Name Product Code
    Peripheral Intravenous (Piv) Infiltration Monitor PMS

    Proprietary Names

    ivWatch Model 400

    Establishment Types

    Manufacture Medical Device