BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    XPAND™ Inflation Device

    DI: 10884450756109 · Model: 10884450756109 · Merit Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    5

    Basic Information

    Brand Name
    XPAND™ Inflation Device
    Primary DI
    10884450756109
    Version / Model
    10884450756109
    Catalog Number
    XP3020
    Company Name
    Merit Medical Systems, Inc.
    Labeler DUNS
    184763290
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2023-11-02
    Public Version
    1
    Public Version Date
    2023-11-10
    Public Version Status
    New
    Public Device Record Key
    fc28f357-978f-4949-845d-8f465cc8409c

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OEQ Angiography/angioplasty kit

    GMDN Terms

    Code Name
    17541 Catheter/overtube balloon inflator, single-use

    Identifiers

    Type ID
    Package 20884450756106
    Primary 10884450756109
    Unit of Use 00884450756102