Identity
- Trade Name
- OxyGeni® FDA UDI
- Generic Name
- Wound therapy oxygenator, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 700000 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851404004084 FDA UDI
- 510(k) Number
- K090681 FDA UDI
- FDA Product Code
- KPJ FDA UDI
- GMDN Term
- Wound therapy oxygenator, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound therapy oxygenator, reusable
OxyGeni® by Electrochemical Oxygen Concepts, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound therapy oxygenator, reusable.
- NATROX® Oxygen Wound Therapy — Inotec Amd , Ltd. · Class II
- NATROX® Oxygen Wound Therapy — Inotec Amd , Ltd. · Class II
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc. · Class II
Cleared under the same submission
K090681 also covers:
- OxyGeni® Dual Port cannula — Electrochemical Oxygen Concepts, Inc.
- OxyGeni® Humidicant Pack — Electrochemical Oxygen Concepts, Inc.
- OxyGeni® Oxygen Delivery Extension Set — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® lite Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc.
- OxySpur® lite Oxygen Diffusion Dressings — Electrochemical Oxygen Concepts, Inc.
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 |
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Manufacturer
- Manufacturer
- Electrochemical Oxygen Concepts, Inc.
Sources (1)
- FDA UDI 857709d8-00af-41fe-93f4-2f9f2c77dbd6 35 fields · synced May 30, 2026