BEUDAMED
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    Better-Bladder

    FDA UDI
    CIRCULATORY TECHNOLOGY INC·00851997007004·

    Bigger Better-Bladder

    FDA UDI
    CIRCULATORY TECHNOLOGY INC·00851997007011·

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

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·March 3, 2016

    BETTER-BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY INC.·Product code DTN·August 3, 2016

    THE BETTER BLADDER

    FDA Adverse Event
    Injury ·CIRCULATORY TECHNOLOGY INC·Product code DWE·May 19, 2010

    THE BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY, INC.·Product code DTN·May 17, 2021

    THE BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY, INC.·Product code DTN·May 19, 2021

    THE BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY, INC.·Product code DTN·May 26, 2021

    THE BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY, INC.·Product code DTN·July 24, 2020

    THE BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY, INC.·Product code DTN·October 18, 2021

    THE BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY INC.·Product code DTN·February 23, 2016

    BIGGER BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY INC.·Product code DTN·June 27, 2016

    THE BIGGER BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY, INC.·Product code DTN·March 25, 2020

    THE BIGGER BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY, INC·Product code DTN·November 25, 2019

    BIGGER BETTER-BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY INC·Product code DTN·August 27, 2019

    BIGGER BETTER BLADDER

    FDA Adverse Event
    Malfunction ·CIRCULATORY TECHNOLOGY INC·Product code DTN·November 21, 2019

    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 Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·July 1, 2016

    The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·June 3, 2009

    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.

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·July 1, 2016

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

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·September 22, 2017