FDA.reportPublic FDA data

OxyGeni®

Primary DI
00851404004084
Brand
OxyGeni®
Company
Electrochemical Oxygen Concepts, Inc.
Model
700000
Device description
OxyGeni® is a wound monitoring low flow tissue oxygenation system that delivers Continuous Diffusion of Oxygen (CDO™) therapy, which is designed for patients who would benefit from wound oxygenation as it may promote wound healing via increased collagen production, angiogenesis, reactive oxygen species generation, and increased cell metabolism. The OxyGeni® System is designed to treat a wide variety of wounds.
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K090681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090681000TANSCU O2Electrochemical Oxygen Concepts, Inc.2009-08-12KPJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851404004084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851404004084008514040040848514040040840851404004084

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 Humidity30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948938092
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851404004015OxySpur® Oxygen Diffusion Dressing"2"" x 2"" Adhesive"6000102023-07-24
00851404004022OxySpur® Oxygen Diffusion Dressing"2"" x 2"" Non-Adhesive"6000112023-07-24
00851404004039OxySpur® Oxygen Diffusion Dressing"4"" x 5"" Adhesive"6000122023-07-24
00851404004046OxySpur® Oxygen Diffusion Dressing"4"" x 5"" Non-Adhesive"6000132023-07-24
00851404004060OxyGeni® Humidicant Pack6000032023-07-24
00851404004077OxyGeni® Dual Port cannula6100002023-07-24
00851404004091OxySpur® Oxygen Diffusion Dressing"5"" x 7"" Non-Adhesive"6000162023-07-24
00851404004107OxySpur® lite Oxygen Diffusion Dressing"2"" x 8"" Adhesive"6000142023-07-24
00851404004114OxyGeni® Oxygen Delivery Extension Set6200002023-07-24
00851404004121OxySpur® lite Oxygen Diffusion Dressings"2"" x 10"" Adhesive"6000152023-07-24

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
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
05060371000004NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2018-10-05
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