OxyGeni®

GUDID 00851404004084

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.

Electrochemical Oxygen Concepts, Inc.

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• Primary Device ID: 00851404004084
• NIH Device Record Key: 857709d8-00af-41fe-93f4-2f9f2c77dbd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyGeni®
• Version Model Number: 700000
• Company DUNS: 948938092
• Company Name: Electrochemical Oxygen Concepts, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851404004084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090681

FDA Product Code

• KPJ: Chamber, Oxygen, Topical, Extremity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

Devices Manufactured by Electrochemical Oxygen Concepts, Inc.

• 00851404004015 - OxySpur® Oxygen Diffusion Dressing: 2023-08-01 OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of w
• 00851404004022 - OxySpur® Oxygen Diffusion Dressing: 2023-08-01 OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of w
• 00851404004039 - OxySpur® Oxygen Diffusion Dressing: 2023-08-01 OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of w
• 00851404004046 - OxySpur® Oxygen Diffusion Dressing: 2023-08-01 OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of w
• 00851404004060 - OxyGeni® Humidicant Pack: 2023-08-01 The OxyGeni® Humidicant Pack is an optional accessory to the OxyGeni® System and is a non-sterile packet, containing an absorb
• 00851404004077 - OxyGeni® Dual Port cannula: 2023-08-01 The OxyGeni® Dual Port cannula is an optional accessory of the OxyGeni® System. It consist of two lengths of flexible tubing e
• 00851404004084 - OxyGeni®: 2023-08-01OxyGeni® 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.
• 00851404004084 - OxyGeni®: 2023-08-01 OxyGeni® is a wound monitoring low flow tissue oxygenation system that delivers Continuous Diffusion of Oxygen (CDO™) therapy
• 00851404004091 - OxySpur® Oxygen Diffusion Dressing: 2023-08-01 OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of w