BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VISIONAIR

    DI: 00860009626805 · Model: 2 · PACIFICMD BIOTECH, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VISIONAIR
    Primary DI
    00860009626805
    Version / Model
    2
    Company Name
    PACIFICMD BIOTECH, LLC
    Labeler DUNS
    093528241
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-07
    Public Version
    1
    Public Version Date
    2023-02-15
    Public Version Status
    New
    Public Device Record Key
    24abe5d5-d83d-461b-adc3-e885bf1a1b1f

    Device Description

    The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).

    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
    MR Unsafe
    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
    BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)
    EOB Nasopharyngoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    17228 Computerized rhinomanometer

    Identifiers

    Type ID
    Primary 00860009626805

    Premarket Submissions

    Submission Number Supplement Number
    K221892 000