BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Advantage II Mask

    Reg #: 3007135420 · FEI: 3007135420 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Carclo Technical Plastics - Latrobe
    Registration Number
    3007135420
    FEI Number
    3007135420
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Depot St
    City
    Latrobe
    State
    PA
    ZIP
    15650
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031935

    Owner / Operator

    Firm Name
    CARCLO TECHNICAL PLASTICS
    Operator Number
    9020456
    Address
    600 DEPOT ST., --
    City
    Latrobe
    State
    PA
    Postal Code
    15650
    Country
    US
    Correspondent
    Brian Kochanski

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Advantage II Mask

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)