BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CoolJect

    Reg #: 3021853802 · FEI: 3021853802 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    VAPOCOOLSHOT, INC
    Registration Number
    3021853802
    FEI Number
    3021853802
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    950 Peninsula Corporate Circle, Suite 2011
    City
    Boca Raton
    State
    FL
    ZIP
    33487
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193349

    Owner / Operator

    Firm Name
    VAPOCOOLSHOT, INC
    Operator Number
    10084483
    Address
    950 Peninsula Corporate Circle, Suite 2011
    City
    Boca Raton
    State
    FL
    Postal Code
    33487
    Country
    US
    Correspondent
    Jacob Leibovici

    Products

    Device Name Product Code
    Vapocoolant Device MLY

    Proprietary Names

    CoolJect

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility