BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UNO 15 Therapy Kit 15x15

    DI: 00849405011545 · Model: U-S1515-5 · GENADYNE BIOTECHNOLOGIES INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UNO 15 Therapy Kit 15x15
    Primary DI
    00849405011545
    Version / Model
    U-S1515-5
    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
    20b4afe2-1ccc-4de3-aab6-e8e6e9bb6818

    Device Description

    The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    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 00849405011545