BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VersaTREK

    Reg #: 1530126 · FEI: 1000515493 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Remel Cleveland, A Division of Remel Inc.
    Registration Number
    1530126
    FEI Number
    1000515493
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 Thermo Fisher Way
    City
    Oakwood Village
    State
    OH
    ZIP
    44146
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032306

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    System, Blood Culturing MDB

    Proprietary Names

    VersaTREK 7106-44 VERSATREK REDOX 1, 40 ML W/STIR BAR 7103-44 VERSATREK REDOX 2, 80ML 7104-44 VERSATREK REDOX 80ML TWIN-PACK 7111-42 VERSATREK MYCO BOTTLES 7102-44 VERSATREK REDOX 1, 80 ML W/STIR BAR 7103-44M VERSATREK REDOX 2M 80ML 7107-44 VERSATREK REDOX 2, EZ DRAW 40ML 7112-42 VERSATREK MYCO GS 7110-44 VERSATREK REDOX 2M, EZ DRAW 40ML 7111-42M VERSATREK MYCO BOTTLES, W/MODIFIED CAP Y52818 VERSATREK 528 W/18 DRAWERS/CTRL MOD Y52818220 VERSATREK 528 W/18 DR/CTRL MOD 220V Y24008 VERSATREK 240 W/8 DRAWERS/CTRL MOD Y24010 VERSATREK 240 W/10 DRAWERS/CTRL MOD Y52816 VERSATREK 528 W/16 DRAWERS/CTRL MOD Y24004 VERSATREK 240 W/4 DRAWERS/CTRL MOD Y24006220 VERSATREK 240 W/6 DR/CTRL MOD, 220V Y52820 VERSATREK 528 W/20 DRAWERS/CTRL M Y24004220 VERSATREK 240 W/4 DR/CTRL MOD, 220V 7150-44 VersaTREK™ CONNECTOR 7115-60 VERSATREK MYCO SUSCEPTIBILITY KIT 7114-42 VERSATREK MYCO AS 7113-42 VERSATREK MYCO PVNA 7120-30 VersaTREK™ Myco Streptomycin Y24008220 VERSATREK 240 W/8 DR/CTRL MOD, 220V Y24010220 VERSATREK 240 W/10 DR/CTRL MOD 220V Y52814 VERSATREK 528 W/14 DRAWERS/CTRL MOD Y52822220 VERSATREK 528 W/22 DR/CTRL MOD 220V Y52822M VERSATREK M 528 W/22 DRAWERS Y52822 VERSATREK 528 W/22 DRAWERS/CTRL MOD

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility