NATROX® Oxygen Wound Therapy NA055-10-01
GUDID 05060371000370
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.
INOTEC AMD LIMITED
Wound therapy oxygenator, single-use| Primary Device ID | 05060371000370 |
| NIH Device Record Key | 65fd3b1b-135e-4af0-8037-39e398c16e26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NATROX® Oxygen Wound Therapy |
| Version Model Number | Oxygen Delivery System |
| Catalog Number | NA055-10-01 |
| Company DUNS | 737446992 |
| Company Name | INOTEC AMD LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com | |
| Phone | 8883549772 |
| sales@natroxwoundcare.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060371000356 [Primary] |
| GS1 | 05060371000370 [Package] Contains: 05060371000356 Package: Shipper [600 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112634
FDA Product Code
| KPJ | Chamber, Oxygen, Topical, Extremity |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-22 |
| Device Publish Date | 2025-12-12 |
On-Brand Devices [NATROX® Oxygen Wound Therapy]
| 05060371000233 | The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres |
| 05060371000202 | The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres |
| 05060371000028 | The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres |
| 05060371000004 | The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic device approxi |
| 05060371000325 | The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres |
| 05060371000363 | The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres |
| 05060371000387 | The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic device approxi |
| 05060371000370 | The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres |
Trademark Results [NATROX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NATROX 79104640 4247923 Live/Registered |
Inotec AMD Limited 2011-04-20 |
 NATROX 79076683 not registered Dead/Abandoned |
NATUREX 2009-10-01 |
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