BEUDAMED
    4 results · 18ms · Sources: EU EUDAMED, US FDA

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

    Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

    FDA Enforcement
    Class II ·Terminated·Circulatory Technology Inc·July 6, 2016

    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.

    FDA Enforcement
    Class II ·Terminated·Circulatory Technology Inc·September 21, 2016

    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)

    FDA Enforcement
    Class II ·Terminated·Circulatory Technology Inc·March 7, 2018

    **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)

    FDA Enforcement
    Class II ·Terminated·Circulatory Technology Inc·March 7, 2018