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Sign in to claim this brandOgenix
US
Last updated May 30, 2026
Information
- Country
- US
- Address
- —
- Website
- ogenix.com
- —
- —
- [email protected]
- Phone
- 2168390202
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 829285464
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Epiflo® | 28-day | FDA UDI | Class II | Active |
| EPIFLO® oxygen delivery cannula | 01-110-100002 | FDA UDI | Class II | Active |
| Epiflo® | 15-day | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 16, 2012 | Z-1477-2012 | — | terminated | 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 date. |
| Mar 24, 2006 | Z-1526-06 | — | terminated | 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 from distribution. |