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OxyGeni®
Electrochemical Oxygen Concepts, Inc. · Model 700000 · UDI-DI 00851404004084
KPJ
Prescription
1
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities
Description
OxyGeni® is a wound monitoring low flow tissue oxygenation system that delivers Continuous Diffusion of Oxygen (CDO™) therapy, which is designed for patients who would benefit from wound oxygenation as it may promote wound healing via increased collagen production, angiogenesis, reactive oxygen species generation, and increased cell metabolism. The OxyGeni® System is designed to treat a wide variety of wounds.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-04-16 | Ogenix Corporation | Ogenix Initiated a voluntary recall for the EPIFLO-15 devices due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May 2013 as the expiry d |
| 2006-03-24 | Ogenix Corporation | Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.