FDA.reportPublic FDA data

OxyGeni® Oxygen Delivery Extension Set

Primary DI
00851404004114
Brand
OxyGeni® Oxygen Delivery Extension Set
Company
Electrochemical Oxygen Concepts, Inc.
Model
620000
Device description
The OxyGeni® Oxygen Delivery Extension Set is an optional accessory of the OxyGeni® System. It is a length of flexible tubing extension with connectors at both ends intended to connect the OxyGeni® Oxygen Generator to the proprietary Oxygen Diffusion Dressings to deliver oxygen (O2) to a wound bed during continuous diffusion of oxygen (CDO™) therapy. It may be secured to the skin using medical tape.
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
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
00851404004114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851404004114008514040041148514040041140851404004114

GMDN Terms#

Term, Definition table
TermDefinition
Wound therapy oxygenator tubingA sterile length of flexible tubing extension with connectors at both ends intended to connect an ambulatory wound therapy oxygenator to a wound therapy oxygenator dressing to deliver oxygen (O2) to a wound bed during continuous diffusion of oxygen (CDO) therapy. It may be secured to the skin using medical tape. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948938092
Device count
1
Lot or batch
true
Expiration 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
00851404004084OxyGeni® 7000002023-07-24
00851404004091OxySpur® Oxygen Diffusion Dressing"5"" x 7"" Non-Adhesive"6000162023-07-24
00851404004107OxySpur® lite Oxygen Diffusion Dressing"2"" x 8"" Adhesive"6000142023-07-24
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
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
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