NATROX® Oxygen Wound Therapy NA055-08

GUDID 05060371000325

The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS),

INOTEC AMD LIMITED

Wound therapy oxygenator, single-use

• Primary Device ID: 05060371000325
• NIH Device Record Key: 350fcb70-93a3-4727-a08a-4ad21806aba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATROX® Oxygen Wound Therapy
• Version Model Number: Oxygen Delivery System
• Catalog Number: NA055-08
• Company DUNS: 737446992
• Company Name: INOTEC AMD LIMITED
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8883549772
• Email: sales@natroxwoundcare.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060371000288 [Primary]
GS1	05060371000295 [Package]; Contains: 05060371000288; Package: [30 Units]; In Commercial Distribution
GS1	05060371000325 [Package]; Contains: 05060371000288; Package: [60 Units]; In Commercial Distribution
GS1	05060371000332 [Package]; Contains: 05060371000288; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112634

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: 2019-06-14
• Device Publish Date: 2019-06-06

On-Brand Devices [NATROX® Oxygen Wound Therapy]

• 05060371000233: The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres
• 05060371000202: The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres
• 05060371000028: The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres
• 05060371000004: The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic device approxi
• 05060371000325: The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres
• 05060371000363: The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dres
• 05060371000387: The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic device approxi