BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Aestiva/5 Compact

    Reg #: 2112667 · FEI: 2112667 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    47
    Establishment Types
    1
    Classifications
    1

    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
    K172045

    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
    Gas-Machine, Anesthesia BSZ

    Proprietary Names

    Aestiva/5 Compact Aisys CS2 Carestation Avance CS2 Pro S/5 Avance Carestation Aestiva 7100 Compact 7100 Ventilator 2VAP W/ARTICULATING ARM Datex-Ohmeda Aestiva/5 with 7100 Ventilator S/5 Aespire with 7900 Ventilator GE Datex Ohmeda Aespire 7900 S/5 Aespire Avance Anesthesia System Aespire 7100 Aisys Carestation Aisys Avance CS2 Carestation Aestiva/5 7100 3VAP W/ARTICULATING ARM Aisys CS2 AESTIVA GOLDSEAL Aestiva 7900 Datex-Ohmeda Aestiva/5 7900 Anesthesia System Aespire 7900 GE Datex-Ohmeda Aestiva/5 Avance CS2 Anesthesia System S/5 Aespire 7100 GE Datex-Ohmeda Aestiva/5 7900 Anesthesia System Aespire 7100/100 Avance Carestation S/5 Avance Avance Aestiva MRI Avance CS2 Aespire 100; Aestiva/5 with 7900 Ventilator Aestiva/5 MRI S/5 Avance Anesthesia System GE Datex Ohmeda Aespire View GE Datex-Ohmeda Aestiva 7900 GE Datex-Ohmeda Avance CS2 Anesthesia System Aespire View Avance CS S/5 Aespire 7900 Datex-Ohmeda Aestiva/5 GE Datex-Ohmeda Aisys CS2 Anesthesia System Aisys CS2 with Et Control Aestiva/5 7900

    Establishment Types

    Manufacture Medical Device