Devices

Monitoring Kit

  • Modelo / Serial
    lot number 3281057
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Monitoring Kit with 30mL Flush Device, Item No. 46076-15 || Product Usage: || The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
  • Manufacturer
    ICU Medical, Inc.
  • 1 Event

Fabricante

ICU Medical, Inc.
  • Dirección del fabricante
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Empresa matriz del fabricante (2017)
    ICU Medical, Inc.
  • Source
    USFDA

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Device Recall Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit
  • Modelo / Serial
    NL950-V - Lot Numbers: 30500R130474 (exp. 8/31/2011); 30500R134098 (exp. 10/31/2011); 30500R139222 (exp. 11/30/2011); 30500R143588 (exp. 1/31/2012); 30500R146383 (exp. 1/31/2012); 30500R147342 (exp. 2/29/2012); and 30500R147899 (exp. 2/29/2012) and  NL950-VC - Lot Numbers: 138999 (exp. 9/30/2011); and 142754 (exp. 12/31/2011).
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia.
  • Descripción del producto
    Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. || This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved through a tunneled technique using the included trocar.
  • Manufacturer
    Integra Neuro Sciences
NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
  • Modelo / Serial
    W050708, W050980, & W050997
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
  • Manufacturer
    Integra Neuro Sciences
Camino® Intracranial Pressure Monitoring Kits
Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcr...
  • Modelo / Serial
    Transpac Monitoring KitsArterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount Item Number: 011-46104-42Lot Numbers: 2841944, 2841945, 2859326, 2865873 & 2869445Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP Item Number: 011-46106-72Lot Numbers: 2841690, 2841691 & 2859331ARTG Number: 206780
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    ICU Medical Australia Pty Ltd
Edwards Pressure Monitoring Kit & Set
  • Modelo / Serial
    Edwards Pressure Monitoring Kit & Set, Model Number: PXMK2043(used on patients requiring intravascular, intracranial, or intrauterine pressure monitoring)Lot numbers: 59994210, 60001412, 60020166 & 60030868ARTG Number: 142521
  • Manufacturer
    Edwards Lifesciences Pty Ltd
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