BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UNO 10x20 Dressing Kit

    DI: 00849405021513 · Model: UNO-0408 · GENADYNE BIOTECHNOLOGIES INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UNO 10x20 Dressing Kit
    Primary DI
    00849405021513
    Version / Model
    UNO-0408
    Company Name
    GENADYNE BIOTECHNOLOGIES INC.
    Labeler DUNS
    006616130
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-09
    Public Version
    1
    Public Version Date
    2023-06-19
    Public Version Status
    New
    Public Device Record Key
    9d0ef007-f810-4ee3-be8d-e6f9e888cd42

    Device Description

    The UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is attached to. The 2nd layer is a super absorbent layer, 3rd layer is a foam layer, and the bottom layer that is skin/ wound contacting is a silicone gel adhesive layer.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    OMP Negative Pressure Wound Therapy Powered Suction Pump

    GMDN Terms

    Code Name
    58202 Negative-pressure wound therapy system, electric, single-use

    Identifiers

    Type ID
    Primary 00849405021513