BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Noxturnal PSG CD

    DI: 15694311111368 · Model: NOX-NOXTPSG_CD · Nox Medical ehf.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Noxturnal PSG CD
    Primary DI
    15694311111368
    Version / Model
    NOX-NOXTPSG_CD
    Catalog Number
    539012
    Company Name
    Nox Medical ehf.
    Labeler DUNS
    365741462
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-24
    Public Version
    4
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    6d8d8f9e-b929-4abe-82b6-c5f1c78425f2

    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
    KZM Device, Muscle Monitoring

    GMDN Terms

    Code Name
    64938 Sleep disorder interpretive software, professional-only

    Identifiers

    Type ID
    Primary 15694311111368

    Customer Contacts

    Phone
    9999999999
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K192469 000