Circulatory Technology Inc

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Description

5 dispositivos en la base de datos

  • Modelo / Serial
    **Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
  • Descripción del producto
    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
  • Modelo / Serial
    **Recall expanded to add additional lot numbers highlighted with "**": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
  • Descripción del producto
    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
  • Modelo / Serial
    Lot # 014648 USE BY: 09/01/2018
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: LA, MI, NY, OH, OR & TX.
  • Descripción del producto
    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 || A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
  • Modelo / Serial
    Lot Numbers: R19229, 015323, 014882, 014602 & 014601
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
  • Descripción del producto
    The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, || Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
  • Modelo / Serial
    Lot # 014603 USE BY: 9/2018
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
  • Descripción del producto
    Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

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Más información acerca de la data acá

  • Dirección del fabricante
    Circulatory Technology Inc, 21 Singworth Street, Oyster Bay NY 11771-3703
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA