BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DioBreeze Cart

    DI: 07290016681130 · Model: FS80023 · FORMATK SYSTEMS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DioBreeze Cart
    Primary DI
    07290016681130
    Version / Model
    FS80023
    Catalog Number
    FS80023
    Company Name
    FORMATK SYSTEMS LTD
    Labeler DUNS
    532396673
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-25
    Public Version
    1
    Public Version Date
    2021-07-05
    Public Version Status
    New
    Public Device Record Key
    f778c948-28d0-481e-b22b-bafcd765f672

    Device Description

    Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha, DioBreeze (Desktop) featuring Mobile system

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)

    GMDN Terms

    Code Name
    40596 Electromechanical device/system transport trolley

    Identifiers

    Type ID
    Primary 07290016681130

    Premarket Submissions

    Submission Number Supplement Number
    K183307 000