Identity
- Trade Name
- NATROX® Oxygen Wound Therapy FDA UDI
- Generic Name
- Wound therapy oxygenator, single-use FDA UDI
- Device Name
- 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. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), FDA UDI
- Model / Reference
- Oxygen Delivery System FDA UDI
- Description
- 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. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), FDA UDI
Identifiers
- Catalog Number
- NA055-08 FDA UDI
- Primary DI / UDI-DI
- 05060371000288 FDA UDI
- 510(k) Number
- K112634 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound therapy oxygenator, single-use
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, single-use.
- EPIFLO® oxygen delivery cannula — Ogenix · Class II
- EPIFLO® — Ogenix · Class II
- EPIFLO® — Ogenix · 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
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 350fcb70-93a3-4727-a08a-4ad21806aba8 37 fields · synced Jun 8, 2026