BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mydcombi

    DI: 00860009909700 · Model: FG-16427 · Eyenovia, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mydcombi
    Primary DI
    00860009909700
    Version / Model
    FG-16427
    Company Name
    Eyenovia, Inc.
    Labeler DUNS
    081095537
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-14
    Public Version
    1
    Public Version Date
    2023-06-22
    Public Version Status
    New
    Public Device Record Key
    f61e9c7f-2227-485c-bd84-212d8398ac92

    Device Description

    A reusable non-sterile component of the MydCombi drug delivery system. Working in conjunction with the Cartridge, this base contains the drive system that allows actuation of the mist. It also contains the power source and interfaces with an external charging source.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HNW Dilator, Lachrymal

    GMDN Terms

    Code Name
    32033 Battery box

    Identifiers

    Type ID
    Primary 00860009909700