NATROX® Oxygen Wound Therapy

Basic Information

• Brand Name: NATROX® Oxygen Wound Therapy
• Primary DI: 05060371000004
• Version / Model: Oxygen Generator
• Catalog Number: NA040
• Company Name: INOTEC AMD LIMITED
• Labeler DUNS: 737446992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-05
• Public Version: 3
• Public Version Date: 2019-06-11
• Public Version Status: Update
• Public Device Record Key: a01d9982-b672-4df4-a0b0-665434467f42

Device Description

The NATROX® Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces oxygen from room air at a rate of approximately 13 mL/hour. 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	878.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62347	Wound therapy oxygenator, reusable	A wearable, battery-powered device designed to actively promote continuous diffusion of oxygen (CDO) in a wound to help heal various types of wounds (e.g., arterial, venous, diabetic or pressure ulcers, skin grafts, burns, postoperative or traumatic wounds). It has oxygen (O2) delivery controls with sensors and displays for flow and pressure, and concentrates O2 from ambient air and delivers it through tubing to the wound bed, typically using a wound therapy oxygenator dressing. A battery charger, carrying case, and disposable humidification pack may be included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060371000004	GS1
Package	05060371000097	GS1		1	In Commercial Distribution
Package	05060371000011	GS1		6	In Commercial Distribution
Package	05060371000257	GS1		24	In Commercial Distribution
Package	05060371000318	GS1		10	In Commercial Distribution
Package	05060371000301	GS1		5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112634	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 85 Degrees Fahrenheit