BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ingenia

    DI: 00884838099746 · Model: SmartPath to Ingenia Elition X · Philips Medical Systems Nederland B.V.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ingenia
    Primary DI
    00884838099746
    Version / Model
    SmartPath to Ingenia Elition X
    Catalog Number
    782118
    Company Name
    Philips Medical Systems Nederland B.V.
    Labeler DUNS
    413819707
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-01
    Public Version
    2
    Public Version Date
    2025-12-15
    Public Version Status
    Update
    Public Device Record Key
    4d2bc430-ba55-43b6-90a2-305db9035fe2

    Device Description

    Upgrade to the Elition X for our customers having an Ingenia 3.0T

    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
    LNH System, Nuclear Magnetic Resonance Imaging
    LNI System, Nuclear Magnetic Resonance Spectroscopic

    GMDN Terms

    Code Name
    37654 Full-body MRI system, superconducting magnet

    Identifiers

    Type ID
    Primary 00884838099746