BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    uMI VM

    DI: 00810030350095 · Model: uMI 550 VM · UIH TECHNOLOGIES LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    uMI VM
    Primary DI
    00810030350095
    Version / Model
    uMI 550 VM
    Company Name
    UIH TECHNOLOGIES LLC
    Labeler DUNS
    117116896
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-11-19
    Public Version
    1
    Public Version Date
    2021-11-29
    Public Version Status
    New
    Public Device Record Key
    0b87d2ea-5c71-4252-ad90-96a3f027db94

    Device Description

    The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals.

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPS System, Tomography, Computed, Emission
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    45143 PET/CT system

    Identifiers

    Type ID
    Primary 00810030350095