BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    BiWaze Clear Dual Lumen Circuit With Face Mask - Child BK291

    Reg #: 3006534321 · FEI: 3006534321 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
    Registration Number
    3006534321
    FEI Number
    3006534321
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ibni Melek Mah., Organize Sanayi Bolgesi
    City
    Tire Izmir
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K231728

    Owner / Operator

    Firm Name
    Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
    Operator Number
    9099982
    Address
    Ibni Melek Mah., Organize Sanayi Bolgesi
    City
    Tire
    State
    Izmir
    Postal Code
    35900
    Country
    TR

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    KEVIN WALLS
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Device, Positive Pressure Breathing, Intermittent NHJ

    Proprietary Names

    BiWaze Clear Dual Lumen Circuit With Face Mask - Child BK291 BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Medium BK287 BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Large BK285 BiWaze Clear Dual Lumen Circuit With Trach Adapter BK293 BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small BK289 BiWaze Clear Dual Lumen Circuit - Acute BK909 BiWaze Clear Dual Lumen Circuit With Face Mask - Infant BK902

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)