BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Ox-Imager

    DI: 00859806007016 · Model: CS · MODULATED IMAGING INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ox-Imager
    Primary DI
    00859806007016
    Version / Model
    CS
    Company Name
    MODULATED IMAGING INC.
    Labeler DUNS
    603130928
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-19
    Public Version
    5
    Public Version Date
    2020-07-01
    Public Version Status
    Update
    Public Device Record Key
    be74ea2a-9de4-42d2-8376-a85a94764286
    Distribution End Date
    2019-10-15

    Device Description

    The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that maps value of: oxygen saturation, oxy-hemoglobin, and deoxy-hemoglobin into 2D/3D visual presentations.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MUD Oximeter, Tissue Saturation

    GMDN Terms

    Code Name
    46615 Tissue saturation oximeter

    Identifiers

    Type ID
    Primary 00859806007016