FDA.reportPublic FDA data

NATROX® Oxygen Wound Therapy

Primary DI
05060371000004
Brand
NATROX® Oxygen Wound Therapy
Company
INOTEC AMD LIMITED
Model
Oxygen Generator
Catalog number
NA040
Device description
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.
Published
2018-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPJChamber, Oxygen, Topical, Extremity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPJChamber, Oxygen, Topical, ExtremityGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112634000NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODPInotec Amd , Ltd.2012-07-03KPJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060371000011PackageGS16In Commercial Distribution
05060371000097PackageGS11In Commercial Distribution
05060371000257PackageGS124In Commercial Distribution
05060371000301PackageGS15In Commercial Distribution
05060371000318PackageGS110In Commercial Distribution
05060371000004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060371000011050603710000115060371000011
05060371000097050603710000975060371000097
05060371000257050603710002575060371000257
05060371000301050603710003015060371000301
05060371000318050603710003185060371000318
05060371000004050603710000045060371000004

GMDN Terms#

Term, Definition table
TermDefinition
Wound therapy oxygenator, reusableA wearable, battery-powered device designed to actively promote continuous diffusion of oxygen (CDO) in a wound to help heal various types of wounds (e.g., arterial, venous, diabetic or pressure ulcers, skin grafts, burns, postoperative or traumatic wounds). It has oxygen (O2) delivery controls with sensors and displays for flow and pressure, and concentrates O2 from ambient air and delivers it through tubing to the wound bed, typically using a wound therapy oxygenator dressing. A battery charger, carrying case, and disposable humidification pack may be included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8883549772sales@natroxwoundcare.com

Regulatory Flags#

DUNS number
737446992
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060371000356NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-10-012025-12-12
05060371000370NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-10-012025-12-12
05060371000349NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-08-012020-07-20
05060371000387NATROX® Oxygen Wound TherapyOxygen GeneratorNA040-H2022-03-08
05060371000363NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-08-012020-07-20
05060371000288NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-082019-06-06
05060371000325NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-082019-06-06
05060371000165NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-102019-03-01
05060371000172NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-202019-03-01
05060371000202NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-102019-03-01
05060371000233NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-202019-03-01
05060371000028NATROX® Oxygen Wound TherapyOxygen Delivery SystemNA055-302018-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060371000356NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2025-12-12
05060371000370NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2025-12-12
00851404004015OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004022OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004039OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004046OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004060OxyGeni® Humidicant PackElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004077OxyGeni® Dual Port cannulaElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004084OxyGeni® Electrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004091OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004107OxySpur® lite Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004114OxyGeni® Oxygen Delivery Extension SetElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004121OxySpur® lite Oxygen Diffusion DressingsElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00860010630600Numobag KitNumotech, Inc.KPJ2023-07-11
00855526003079EPIFLO®OgenixKPJ2023-06-08
00855526003086EPIFLO®OgenixKPJ2023-06-08
05060371000387NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2022-03-08
05060371000349NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2020-07-20
05060371000363NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2020-07-20
05060371000288NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-06-06
05060371000325NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-06-06
05060371000165NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000172NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000202NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000233NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000028NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2018-10-05
05391518740027Hyperbox SystemAOTI LIMITEDKPJ2017-07-17
53915187400272Hyperbox SystemAOTI LIMITEDKPJ2017-07-17
05391518749990Hyperbox SystemAOTI LIMITEDKPJ2017-07-05
53915187499900Hyperbox SystemAOTI LIMITEDKPJ2017-07-05