BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NTRAINER

    DI: 50885380195561 · Model: 510NT · INNARA HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    NTRAINER
    Primary DI
    50885380195561
    Version / Model
    510NT
    Catalog Number
    510NT
    Company Name
    INNARA HEALTH, INC.
    Labeler DUNS
    809608719
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2023-07-03
    Public Version
    2
    Public Version Date
    2024-02-02
    Public Version Status
    Update
    Public Device Record Key
    97076f46-ad7b-4ee0-af09-9ddd637ec476

    Device Description

    NTrainer System 2.0 Patient Receiver Tubes (10-pack)

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HCC Device, biofeedback

    GMDN Terms

    Code Name
    11614 Evoked-potential graphic recording system

    Identifiers

    Type ID
    Unit of Use 10885380195556
    Primary 50885380195561

    Premarket Submissions

    Submission Number Supplement Number
    K071866 000