NATROX® Oxygen Wound Therapy NA040
GUDID 05060371000004
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.
INOTEC AMD LIMITED
Wound therapy oxygenator, reusable| Primary Device ID | 05060371000004 |
| NIH Device Record Key | a01d9982-b672-4df4-a0b0-665434467f42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NATROX® Oxygen Wound Therapy |
| Version Model Number | Oxygen Generator |
| Catalog Number | NA040 |
| Company DUNS | 737446992 |
| Company Name | INOTEC AMD LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8883549772 |
| sales@natroxwoundcare.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060371000004 [Primary] |
| GS1 | 05060371000011 [Package] Package: [6 Units] In Commercial Distribution |
| GS1 | 05060371000097 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 05060371000257 [Package] Contains: 05060371000011 Package: [24 Units] In Commercial Distribution |
| GS1 | 05060371000301 [Package] Package: [5 Units] In Commercial Distribution |
| GS1 | 05060371000318 [Package] Package: [10 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 | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-11 |
| Device Publish Date | 2018-10-05 |
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 |
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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