BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NAPA (Nocturnal Airway Patency Appliance)

    DI: 00810002220265 · Model: 3014680794 · JOHN'S DENTAL LABORATORY INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NAPA (Nocturnal Airway Patency Appliance)
    Primary DI
    00810002220265
    Version / Model
    3014680794
    Company Name
    JOHN'S DENTAL LABORATORY INC
    Labeler DUNS
    016649253
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-03
    Public Version
    2
    Public Version Date
    2023-12-25
    Public Version Status
    Update
    Public Device Record Key
    cbbeb6e4-dfc3-4c29-85b6-a9ea9d64dde0

    Device Description

    A removable intraoral device intended to reduce both mild Obstructive Sleep Apnea and snoring. This is a reusable device.

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LQZ Device, Jaw Repositioning

    GMDN Terms

    Code Name
    47526 Mandible-repositioning sleep-disordered breathing orthosis

    Identifiers

    Type ID
    Primary 00810002220265