OxyGeni® Oxygen Delivery Extension Set

GUDID 00851404004114

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.

Electrochemical Oxygen Concepts, Inc.

Wound therapy oxygenator tubing

• Primary Device ID: 00851404004114
• NIH Device Record Key: 9173fc55-2d65-45f2-b44a-baa33342ae71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyGeni® Oxygen Delivery Extension Set
• Version Model Number: 620000
• Company DUNS: 948938092
• Company Name: Electrochemical Oxygen Concepts, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851404004114 [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®: 2023-08-01 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