BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EsoCool Esophageal Cooling Catheter

    Reg #: 3017866427 · FEI: 3017866427 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NUVAIRA, INC.
    Registration Number
    3017866427
    FEI Number
    3017866427
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6500 Wedgwood Rd N Ste 100
    City
    Maple Grove
    State
    MN
    ZIP
    55311
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233357

    Owner / Operator

    Firm Name
    Nuvaira, Inc.
    Operator Number
    10091478
    Address
    6500 Wedgwood Road North, Suite 100
    City
    Maple Grove
    State
    MN
    Postal Code
    55311
    Country
    US
    Correspondent
    John Carline

    Products

    Device Name Product Code
    Esophageal Thermal Regulation And Gastric Suctioning Device PLA

    Proprietary Names

    EsoCool Esophageal Cooling Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device