OxyGeni®

Basic Information

• Brand Name: OxyGeni®
• Primary DI: 00851404004084
• Version / Model: 700000
• Company Name: Electrochemical Oxygen Concepts, Inc.
• Labeler DUNS: 948938092
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-24
• Public Version: 1
• Public Version Date: 2023-08-01
• Public Version Status: New
• Public Device Record Key: 857709d8-00af-41fe-93f4-2f9f2c77dbd6

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	878.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62347	Wound therapy oxygenator, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851404004084	GS1

Premarket Submissions

Submission Number	Supplement Number
K090681	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 86 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 30 – 95 Percent (%) Relative Humidity