OxyGeni® Humidicant Pack

GUDID 00851404004060

The OxyGeni® Humidicant Pack is an optional accessory to the OxyGeni® System and is a non-sterile packet, containing an absorbent polymeric gel saturated with water, intended to help provide optimal humidity for the OxyGeni® Oxygen Generator when ambient relative humidity is low during continuous diffusion of oxygen (CDO™) therapy.

Electrochemical Oxygen Concepts, Inc.

Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack Wound therapy oxygenator humidification pack

• Primary Device ID: 00851404004060
• NIH Device Record Key: abe3963c-5da2-4e3b-bb45-4fa3b5f203c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyGeni® Humidicant Pack
• Version Model Number: 600003
• 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: 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	00851404004060 [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: 2023-08-01The OxyGeni® Humidicant Pack is an optional accessory to the OxyGeni® System and is a non-sterile packet, containing an absorbent polymeric gel saturated with water, intended to help provide optimal humidity for the OxyGeni® Oxygen Generator when ambient relative humidity is low during continuous diffusion of oxygen (CDO™) therapy.
• 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