Devices

EPIFLO

  • Model / Serial
    AL 041 (only lot involved); model EPIFLO-15.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of FL, MN, OH and the county of Turkey.
  • Product Description
    EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. || The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.
  • Manufacturer
    Ogenix Corporation
  • 1 Event

Manufacturer

Ogenix Corporation
  • Manufacturer Address
    Ogenix Corporation, 3401 Enterprise Pkwy, Suite 340, Beachwood OH 44122-7341
  • Manufacturer Parent Company (2017)
    Ogenix Corporation
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall EpiFLO SD
  • Model / Serial
    A total of 18 lot codes were distributed. They are as follows: 23105A, 31805A, 34905A, 01006A, 00906A, 35505A, 34705A, 00606A, 35005A, 35305A, 01006A, 01706A, 01206A, 02006A, 02306A, 01806A, 01106A, and 30105A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to customers located in the following states: IN, MD, TX, MA, MI, MN, OH, FL, and NB.
  • Product Description
    Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.
  • Manufacturer
    Ogenix Corporation