FDA.reportPublic FDA data

EPIFLO®

Primary DI
00855526003079
Brand
EPIFLO®
Company
Ogenix
Model
28-day
Catalog number
01-130-100010
Device description
Transdermal Continuous O2 Therapy Oxygen Concentrator and 6 Cannulas
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
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
K190742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190742000EPIFLO-28Neogenix, LLC Dba Ogenix2019-12-13KPJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855526003086PackageGS110In Commercial Distribution
00855526003079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855526003086008555260030868555260030860855526003086
00855526003079008555260030798555260030790855526003079

GMDN Terms#

Term, Definition table
TermDefinition
Wound therapy oxygenator, single-useA 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; burns; postoperative or traumatic wounds). It is intended to concentrate oxygen (O2) from ambient air and pump it through an included sterile delivery tube intended to be secured to the wound bed, which is typically covered by an absorbent and occlusive dressing. It is intended to be used continuously over a prescribed period, being discarded and replaced along with the dressing as required. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
7817026732lcali@ogenix.com

Regulatory Flags#

DUNS number
829285464
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855526003086EPIFLO®28-day01-130-1000102023-06-08
00855526003024EPIFLO® oxygen delivery cannula01-110-1000022016-10-07
00855526003055EPIFLO®15-day01-120-1000102016-10-07
00855526003062EPIFLO®15-day01-120-1000102016-10-07

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
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