BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ohmega R

    DI: 08717775955016 · Model: G2-1 · Medical Measurement Systems B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ohmega R
    Primary DI
    08717775955016
    Version / Model
    G2-1
    Company Name
    Medical Measurement Systems B.V.
    Labeler DUNS
    416277333
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    5fd134a6-8c54-40d5-b455-cfb1a06142a9

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    FFX SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

    GMDN Terms

    Code Name
    11600 Oesophageal motility analysis system

    Identifiers

    Type ID
    Primary 08717775955016

    Premarket Submissions

    Submission Number Supplement Number
    K060166 000