Identity
- Trade Name
- NATROX® Oxygen Wound Therapy FDA UDI
- Generic Name
- Wound therapy oxygenator, reusable FDA UDI
- Device Name
- The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces oxygen from room air at a rate of approximately 13 mL/hour. The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. FDA UDI
- Model / Reference
- Oxygen Generator FDA UDI
- Description
- The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces oxygen from room air at a rate of approximately 13 mL/hour. The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. FDA UDI
Identifiers
- Catalog Number
- NA040 FDA UDI
- Primary DI / UDI-DI
- 05060371000004 FDA UDI
- 510(k) Number
- K112634 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound therapy oxygenator, reusable
NATROX® Oxygen Wound Therapy by Inotec Amd , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound therapy oxygenator, reusable.
- OxySpur® Oxygen Diffusion Dressing — Electrochemical Oxygen Concepts, Inc. · Class II
- OxyGeni® — Electrochemical Oxygen Concepts, Inc. · Class II
- NATROX® Oxygen Wound Therapy — Inotec Amd , Ltd. · Class II
Cleared under the same submission
K112634 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 |
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Manufacturer
- Manufacturer
- Inotec Amd , Ltd.
Sources (1)
- FDA UDI a01d9982-b672-4df4-a0b0-665434467f42 37 fields · synced May 30, 2026