NATROX® Oxygen Wound Therapy NA055-30

GUDID 05060371000028

The NATROX® System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhanc

INOTEC AMD LIMITED

Wound therapy oxygenator, single-use

• Primary Device ID: 05060371000028
• NIH Device Record Key: b775c156-55e3-4156-9c47-4f0a67db2097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATROX® Oxygen Wound Therapy
• Version Model Number: Oxygen Delivery System
• Catalog Number: NA055-30
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060371000028 [Primary]
GS1	05060371000059 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	05060371000066 [Package]; Package: [6 Units]; In Commercial Distribution
GS1	05060371000240 [Package]; Package: [15 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-04
• Device Publish Date: 2018-10-05

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