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OxyGeni® Oxygen Delivery Extension Set
Electrochemical Oxygen Concepts, Inc. · Model 620000 · UDI-DI 00851404004114
KPJ
Prescription
1
510(k) clearances
2
Adverse events
2
Recalls
17
Facilities
Description
The OxyGeni® Oxygen Delivery Extension Set is an optional accessory of the OxyGeni® System. It is a length of flexible tubing extension with connectors at both ends intended to connect the OxyGeni® Oxygen Generator to the proprietary Oxygen Diffusion Dressings to deliver oxygen (O2) to a wound bed during continuous diffusion of oxygen (CDO™) therapy. It may be secured to the skin using medical tape.
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.