OxySpur® lite Oxygen Diffusion Dressings 600015

GUDID 00851404004121

OxySpur® lite Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are constructed with a non-adherent mesh layer directly adjacent to the wound, one lite absorbent hydrophilic foam layer with channels for oxygen distribution, covered by an occlusive film, and an adhesive border. The OxySpur® lite is to be used on wounds with minimal to low exudate, such as later in the wound healing cycle when wound exudate levels decrease.

Electrochemical Oxygen Concepts, Inc.

Wound therapy oxygenator dressing

• Primary Device ID: 00851404004121
• NIH Device Record Key: af9fbe93-fd91-457d-ae37-2f287521b616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxySpur® lite Oxygen Diffusion Dressings
• Version Model Number: 2" x 10" Adhesive
• Catalog Number: 600015
• 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	00851404004121 [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: true

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