BEUDAMED
    325 results · 56ms · Sources: EU EUDAMED, US FDA

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    Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.

    FDA Recall
    Terminated ·Battelle Memorial Institute·Product code QKY·August 13, 2020

    Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.

    FDA Enforcement
    Class II ·Terminated·Battelle Memorial Institute·November 4, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 6, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 4, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 6, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 6, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 6, 2020

    CCDS CRITICAL CARE DECONTAMINATION SYSTEM

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 5, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·October 30, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 5, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 5, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 5, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 4, 2020

    N/A

    FDA Adverse Event
    Injury ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·September 8, 2020

    BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QLA·September 8, 2020

    NA

    FDA Adverse Event
    Injury ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 24, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 6, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 6, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 5, 2020

    NA

    FDA Adverse Event
    Malfunction ·BATTELLE MEMORIAL INSTITUTE·Product code QKY·November 6, 2020