BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DISPOSABLE AAMI ISOLATION GOWN LEVEL 3

    Reg #: 3013269506 · FEI: 3013269506 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TWO ONE TWO NEW YORK, INC.
    Registration Number
    3013269506
    FEI Number
    3013269506
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    60 Heartland Blvd
    City
    Edgewood
    State
    NY
    ZIP
    11717
    Country
    US

    Owner / Operator

    Firm Name
    Two One Two New York, Inc.
    Operator Number
    10077084
    Address
    60 Heartland Blvd
    City
    Edgewood
    State
    NY
    Postal Code
    11717
    Country
    US
    Correspondent
    Christina Fumei

    Products

    Device Name Product Code
    Non-Surgical Gown OEA

    Proprietary Names

    DISPOSABLE AAMI ISOLATION GOWN LEVEL 3 LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000XL DISPOSABLE SURGICAL GOWN AAMI LEVEL 2 NON-STERILE REUSABLE ISOLATION GOWN LEVEL 1 ANSI/AAMI LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000L IIJA COMPLIANT DISPOSABLE ISOLATION GOWN LEVEL 2 ANSI/AAMI DISPOSABLE ISOLATION GOWN ANSI/AAMI LEVEL 2 DISPOSABLE ISOLATION GOWN LEVEL 1 ANSI/AAMI DISPOSABLE ISOLATION GOWN LEVEL 3 ANSI/AAMI

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)