BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VersaTREK

    Reg #: 1924669 · FEI: 1924669 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    REMEL, INC.
    Registration Number
    1924669
    FEI Number
    1924669
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12076 Santa Fe Trail Dr
    City
    LENEXA
    State
    KS
    ZIP
    66215
    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 Manufacture Medical Device