BEUDAMED
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    QCU ANALYTICAL SOFTWARE PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLUCURONIDES HYDROLYSIS QC

    FDA UDI
    UTAK LABORATORIES, INC.·B800GLUCQCUCCHS0·GLUCURONIDES HYDROLYSIS QC

    HYDROLYSIS QC

    FDA UDI
    UTAK LABORATORIES, INC.·B800QCUFLW0·HYDROLYSIS QC

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·February 19, 2015

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 27, 2015

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·October 1, 2014

    THC QC

    FDA UDI
    UTAK LABORATORIES, INC.·B800THCQCUFNJSTL0·THC QC

    TOF WATCH

    FDA Adverse Event
    Malfunction ·ORGANON IRELAND LIMITED·Product code KOI·December 18, 2018

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·January 7, 2016

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·October 5, 2016

    Dengue Virus Antigen Assay

    FDA classification
    FDA Class 2 ·Dengue Virus Antigen Assay

    DCI

    FDA UDI
    DCI International, LLC·00810021432946·Automatic Control Unit

    ACU 1060.2 Transtracheal Catheter

    FDA UDI
    INSTRUMENTATION INDUSTRIES, INCORPORATED·M996ACU106020·ACU 1060.2 Transtracheal Catheter provides trac...

    ACU 1060.1 Transtracheal Catheter

    FDA UDI
    INSTRUMENTATION INDUSTRIES, INCORPORATED·M996ACU106010·ACU 1060.1 Transtracheal Catheter provides trac...

    Focus

    FDA UDI
    AIRSEP CORPORATION·M638AS0781CU0·Portable Oxygen Concentrator, 2 LPM, Re-manufac...

    FreeStyle 5

    FDA UDI
    CAIRE INC.·M766AS0771CU0·FREESTYLE 5 PORTABLE OXYGEN CONCENTRATOR, 1-5LP...

    FreeStyle

    FDA UDI
    CAIRE INC.·M766AS0951CU0·FREESTYLE OXYGEN CONCENTRATOR, 1-3LPM, REFURBISHED

    Focus

    FDA UDI
    CAIRE INC.·M766AS0871CU0·FOCUS PORTABLE OXYGEN CONCENTRATOR, PULSE DOSE,...

    FreeStyle 5

    FDA UDI
    AIRSEP CORPORATION·M638AS0771CU0·Portable Oxygen Concentrator, 1-5 LPM, Re-manuf...

    FreeStyle

    FDA UDI
    AIRSEP CORPORATION·M638AS0951CU0·Portable Oxygen Concentrator, 1-3 LPM, Re-manuf...