BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prosomnus IA MicrO2 with Patient Monitoring

    DI: 00863039000447 · Model: MicrO2 with Monitoring · PROSOMNUS SLEEP TECHNOLOGIES
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prosomnus IA MicrO2 with Patient Monitoring
    Primary DI
    00863039000447
    Version / Model
    MicrO2 with Monitoring
    Company Name
    PROSOMNUS SLEEP TECHNOLOGIES
    Labeler DUNS
    075438768
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-21
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    1411f041-95b6-4dc6-9db9-90f4661848db

    Device Description

    Obstructive Sleep Apnea Device with twin mated posts and Patient Monitoring

    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
    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
    PLC Sleep Appliances With Patient Monitoring

    GMDN Terms

    Code Name
    47526 Mandible-repositioning sleep-disordered breathing orthosis

    Identifiers

    Type ID
    Primary 00863039000447