BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    iNAP One

    DI: 04719878321105 · Model: Starter Kit · SOMNICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iNAP One
    Primary DI
    04719878321105
    Version / Model
    Starter Kit
    Company Name
    SOMNICS, INC.
    Labeler DUNS
    657169335
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-07
    Public Version
    1
    Public Version Date
    2023-03-15
    Public Version Status
    New
    Public Device Record Key
    874aa0d5-6412-452a-872a-b0487da4f268

    Device Description

    R07-B, C07, T01, I07H, A03*3, P01, ZeeBud

    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
    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
    OZR Intraoral Pressure Gradient Device

    GMDN Terms

    Code Name
    65078 Intraoral negative-pressure sleep apnoea unit

    Identifiers

    Type ID
    Primary 04719878321105

    Customer Contacts

    Phone
    1-833-766-6427
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K193460 000