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    CLOUDS OF CARE NV

    Manufacturer
    🇧🇪 Belgium

    CLOUDS OF CARE NV

    Manufacturer
    🇧🇪 Belgium·SGS Belgium NV

    Persyst ESI powered by Epilog

    FDA UDI
    Clouds of Care·05430000733038·Persyst ESI powered by Epilog provides Electric...

    Persyst ESI powered by Epilog

    FDA UDI
    Clouds of Care·05430000733045·Persyst ESI powered by Epilog provides Electric...

    PreOp

    FDA UDI
    Clouds of Care·05430000733021·PreOp is active medical device software (MSDW) ...

    PreOp

    FDA UDI
    Clouds of Care·05430000733007·PreOp is intended for use by a trained/qualifie...

    Clouds of Care NV

    FDA registration
    Clouds of Care NV·1 product·🇧🇪 Belgium

    BE24/000001249

    Certificate
    MDR QMS·CLOUDS OF CARE NV·SGS Belgium NV

    Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical·January 29, 2025

    OMNIPOD 5 POD

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·March 5, 2025

    OMNIPOD 5 POD

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·March 28, 2025

    OMNIPOD 5 PODS

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·March 28, 2025

    OMNIPOD 5 POD

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·February 12, 2025

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·April 10, 2025

    OMNIPOD 5 PODS

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·March 14, 2025

    OMNIPOD 5 PODS

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·February 18, 2025

    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000

    FDA Enforcement
    Class II ·Ongoing·St. Jude Medical·January 29, 2025

    OMNIPOD 5 PODS

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·February 24, 2025

    OMNIPOD 5 PODS

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·March 17, 2025

    OMNIPOD 5 PODS

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·February 25, 2025