Identity
- Trade Name
- EPIFLO® FDA UDI
- Generic Name
- Wound therapy oxygenator, single-use FDA UDI
- Device Name
- Transdermal Continuous O2 Therapy. Oxygen Concentrator FDA UDI
- Model / Reference
- 15-day FDA UDI
- Description
- Transdermal Continuous O2 Therapy. Oxygen Concentrator FDA UDI
Identifiers
- Catalog Number
- 01-120-100010 FDA UDI
- Primary DI / UDI-DI
- 00855526003055 FDA UDI
- 510(k) Number
- K120764 FDA UDI
- FDA Product Code
- KPJ FDA UDI
- GMDN Term
- Wound therapy oxygenator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound therapy oxygenator, single-use
Epiflo® by Ogenix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound therapy oxygenator, single-use.
- NATROX® Oxygen Wound Therapy — Inotec Amd , Ltd. · Class II
- NATROX® Oxygen Wound Therapy — Inotec Amd , Ltd. · Class II
- NATROX® Oxygen Wound Therapy — Inotec Amd , Ltd. · Class II
- NATROX® Oxygen Wound Therapy — Inotec Amd , Ltd. · Class II
- NATROX® Oxygen Wound Therapy — Inotec Amd , Ltd. · Class II
- EPIFLO® oxygen delivery cannula — Ogenix · Class II
- EPIFLO® — Ogenix · Class II
Cleared under the same submission
K120764 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ogenix
Sources (1)
- FDA UDI cdf601ca-68c5-46f7-9a6e-1de9588b2296 36 fields · synced May 31, 2026