BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·February 7, 2018

    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 31, 2016

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.

    FDA Enforcement
    Class II ·Terminated·ICU·July 19, 2017

    7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.anoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7089-001

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave ¿, NanoClave¿ T-Connector, Rotating Luer, Part No. A1000, Item No. 011-A1094 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·April 18, 2018

    6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·April 18, 2018

    8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014