BEUDAMED
    34 results · 25ms · Sources: EU EUDAMED, US FDA

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

    Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·June 24, 2015

    Alaris Pump Module model 8100

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·July 19, 2017

    Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00 -SmartSite Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01 -Infusion Set Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN, FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion 630-00650 Rev 00 Production Usage: Administration sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male luer with spin lock and tubing with different length of tubing.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·November 14, 2018

    Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·March 29, 2017

    Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·March 23, 2016

    Alaris PC units, Model No. 8015. Infusion pump.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·April 1, 2015

    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·February 12, 2014

    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·February 12, 2014

    SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·July 16, 2014

    Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·May 11, 2016

    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

    FDA Enforcement
    Class II ·Terminated·Carefusion 303 Inc·February 27, 2013

    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·October 2, 2013

    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·December 11, 2013

    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·December 30, 2015

    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·February 24, 2016

    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·November 11, 2015

    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·December 30, 2015

    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·March 22, 2017

    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·July 6, 2016

    SmartSite Extension Set, Model No. 20029E, intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·April 23, 2014