natroxwoundcare.comNATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
INOTEC AMD LTD.
INOTEC AMD LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014767695 | 3014767695 | INOTEC AMD LTD. | 1 | N | 2026-01-01 | Ground Floor Unit 7340, Building 7300, Cambridge Research Park Waterbeach Cambridge Cambridgeshire GB CB25 9PD |
| 3014833775 | 3014833775 | Inotec AMD Inc. | 1 | Y | 2026-01-01 | 1350 4th Street Drive NW Hickory NC US 28601 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05060371000004 | NATROX® Oxygen Wound Therapy - The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic deviceapproximately the size of a cell phone, containing an oxygen generator that produces oxygen fromroom air at a rate of approximately 13 mL/hour. The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. | 8883549772 | sales@natroxwoundcare.com |
| 05060371000288 | NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. A small diameter tube transmits the oxygen to thewound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System(ODS), | 8883549772 | sales@natroxwoundcare.com |
| 05060371000325 | NATROX® Oxygen Wound Therapy - 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), | 8883549772 | sales@natroxwoundcare.com |
| 05060371000349 | NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. A small diameter tube transmits the oxygen to thewound bed, where the wound is exposed to the oxygen atmosphere. | 8883549772 | sales@natroxwoundcare.com |
| 05060371000356 | NATROX® Oxygen Wound Therapy - 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. | 8883549772 | sales@natroxwoundcare.com |
| 05060371000363 | NATROX® Oxygen Wound Therapy - 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), | 8883549772 | sales@natroxwoundcare.com |
| 05060371000370 | NATROX® Oxygen Wound Therapy - 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. | 8883549772 | sales@natroxwoundcare.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 222359 | 1913883935 | K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | KPJ | 2012-07-03 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KPJ | 2 | 2012-07-03 |
PMN#
GUDID#
NATROX® Oxygen Wound Therapy - 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.
2025-12-12
NATROX® Oxygen Wound Therapy - 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.
2025-12-12
NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. A small diameter tube transmits the oxygen to thewound bed, where the wound is exposed to the oxygen atmosphere.
2020-07-20
NATROX® Oxygen Wound Therapy - The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic deviceapproximately the size of a cell phone, containing an oxygen generator that produces oxygen fromroom air at a rate of approximately 13 mL/hour. The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.
2022-03-08
NATROX® Oxygen Wound Therapy - 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),
2020-07-20
NATROX® Oxygen Wound Therapy - 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),
2019-06-06
NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. A small diameter tube transmits the oxygen to thewound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System(ODS),
2019-06-06
NATROX® Oxygen Wound Therapy - The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic deviceapproximately the size of a cell phone, containing an oxygen generator that produces oxygen fromroom air at a rate of approximately 13 mL/hour. The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.
2018-10-05
NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhanc
2019-03-01
NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhanc
2019-03-01
NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. A small diameter tube transmits the oxygen to thewound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System(ODS),
2019-03-01
NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. A small diameter tube transmits the oxygen to thewound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System(ODS),
2019-03-01
NATROX® Oxygen Wound Therapy - The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusivedressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing forchronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. A small diameter tube transmits the oxygen to thewound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System(ODS),
2018-10-05