AccessGUDID - DEVICE: NATROX® Oxygen Wound Therapy (05060371000004)

GUDID

Device Identifier (DI) Information

Brand Name: NATROX® Oxygen Wound Therapy
Version or Model: Oxygen Generator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA040
Company Name: INOTEC AMD LIMITED

Primary DI Number: 05060371000004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 737446992 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPJ	Chamber, Oxygen, Topical, Extremity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112634	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a01d9982-b672-4df4-a0b0-665434467f42
Public Version Date: June 11, 2019
Public Version Number: 3
DI Record Publish Date: October 05, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
05060371000097	1	05060371000004	In Commercial Distribution
05060371000011	6	05060371000004	In Commercial Distribution
05060371000257	24	05060371000011	In Commercial Distribution
05060371000318	10	05060371000004	In Commercial Distribution
05060371000301	5	05060371000004	In Commercial Distribution