BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·January 27, 2016

    GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·January 27, 2016

    DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 4, 2018

    GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·November 11, 2020

    GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·November 11, 2020

    DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 4, 2018

    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 28, 2014

    D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·June 3, 2015

    GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·January 27, 2016

    Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 18, 2013

    Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·November 11, 2020

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014

    CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. The CARESCAPE R860 ventilator is not a pulmonary function calculation device. The system is designed for facility use, including within facility transport, and should only be used under the orders of a clinician.

    FDA Enforcement
    Class II ·Terminated·Datex-Ohmeda, Inc.·June 27, 2018

    The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.

    FDA Enforcement
    Class II ·Terminated·Datex-Ohmeda, Inc.·August 15, 2018

    Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, OBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/CE Plug, ASSY-LAU, Omnibed Czech S-PH w/Nist O2 w/Reus Probe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Czech S-PH w/Reusable Probe CE Power Cord, Finished good - Make, Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/Ce Plug, ASSY-LAU, Omnibed Indonesian S-GR W/Reuseable Probe CE Plug, Finished good - Make, ASSY-LAU, Omnibed ENG S-Gr w/REUProbe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Portuguese S-PH w/NIST O2w/Reusable Probe CE Power Cord, Finished good - Make. Incubator, Neonatal, Warmer, Infant radiant

    FDA Enforcement
    Class II ·Ongoing·DATEX--OHMEDA, INC.·July 12, 2023

    Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal

    FDA Enforcement
    Class II ·Ongoing·DATEX--OHMEDA, INC.·July 12, 2023

    Beside panel FRU (Field Replacement Units) Kits

    FDA Enforcement
    Class II ·Ongoing·DATEX--OHMEDA, INC.·July 12, 2023

    GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·January 27, 2016

    GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·January 27, 2016

    Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 21, 2018