OxySpur® Oxygen Diffusion Dressing 600013

GUDID 00851404004046

OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are a multi-layer construct with a highly absorbent hydrophilic foam layer directly adjacent to the wound, a highly absorbent hydrophilic foam layer with channels for oxygen distribution, and a super absorbent polymeric laminate, all of which are covered by an occlusive film.

Electrochemical Oxygen Concepts, Inc.

Wound therapy oxygenator, reusable

• Primary Device ID: 00851404004046
• NIH Device Record Key: b1244b95-722b-4eaf-8257-a8aee2bc3ca9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxySpur® Oxygen Diffusion Dressing
• Version Model Number: 4" x 5" Non-Adhesive
• Catalog Number: 600013
• 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	00851404004046 [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

On-Brand Devices [OxySpur® Oxygen Diffusion Dressing]

• 00851404004091: OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni
• 00851404004046: OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni
• 00851404004039: OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni
• 00851404004022: OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni
• 00851404004015: OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni