BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FlexTEMP System, Jacket - 989803178181

    Reg #: 1064859 · FEI: 3002897588 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLYZEN, INC.
    Registration Number
    1064859
    FEI Number
    3002897588
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1041 CLASSIC ROAD
    City
    APEX
    State
    NC
    ZIP
    27539
    Country
    US

    Regulatory Submissions

    510(k) Number
    K124061

    Owner / Operator

    Firm Name
    POLYZEN, INC.
    Operator Number
    9034880
    Address
    195 O'Neill Drive
    City
    Quakertown
    State
    PA
    Postal Code
    18951
    Country
    US
    Correspondent
    Kitu Patel

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    FlexTEMP System, Jacket - 989803178181

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)