BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Polysmith Version 12.2

    DI: 00817111021257 · Model: 12.2 · Neurotronics, LLC
    View on AccessGUDID
    Product Codes
    6
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Polysmith Version 12.2
    Primary DI
    00817111021257
    Version / Model
    12.2
    Company Name
    Neurotronics, LLC
    Labeler DUNS
    036405363
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-28
    Public Version
    2
    Public Version Date
    2023-04-14
    Public Version Status
    Update
    Public Device Record Key
    73a71a61-5435-4741-8844-229c1a71de0e

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
    OLV Standard Polysomnograph With Electroencephalograph
    DQA Oximeter
    MNR Ventilatory Effort Recorder
    GWL Amplifier, Physiological Signal
    MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

    GMDN Terms

    Code Name
    64938 Sleep disorder interpretive software, professional-only

    Identifiers

    Type ID
    Primary 00817111021257

    Premarket Submissions

    Submission Number Supplement Number
    K062943 000
    K092699 000
    K142774 000
    K161650 000