BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EAC

    Reg #: 2112667 · FEI: 2112667 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Datex-Ohmeda, Inc.
    Registration Number
    2112667
    FEI Number
    2112667
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3030 Ohmeda Drive
    City
    MADISON
    State
    WI
    ZIP
    53718
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132530

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    Apparatus, Gas-Scavenging CBN
    Gas-Machine, Anesthesia BSZ

    Proprietary Names

    EAC ALADIN2 ENF-EASY-FIL ALADIN2 SEV EASY-FIL B ALADIN2 DES SAF-FIL Aisys CS2 Carestation Aladin2 GE Datex-Ohmeda Aisys CS2 Anesthesia System Aisys CS2 Enhanced Aladin Cassette ALADIN2 ISO EASY-FIL ALADIN2 SEV QUIK-FIL A ALADIN2 SEV QUIK-FIL ALADIN2 SEV EASY-FIL ALADIN2 DES SAF-FIL B ALADIN2 SEV EASY-FIL A ALADIN2 DES FIXED-FIL

    Establishment Types

    Manufacture Medical Device