AccessGUDID - DEVICE: NATROX® Oxygen Wound Therapy (05060371000165)

GUDID

Device Identifier (DI) Information

Brand Name: NATROX® Oxygen Wound Therapy
Version or Model: Oxygen Delivery System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA055-10
Company Name: INOTEC AMD LIMITED

Primary DI Number: 05060371000165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 737446992 *Terms of Use

Device Description: 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),

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":	Yes
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?
59124	Wound therapy oxygenator, single-use	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; burns; postoperative or traumatic wounds). It is intended to concentrate oxygen (O2) from ambient air and pump it through an included sterile delivery tube intended to be secured to the wound bed, which is typically covered by an absorbent and occlusive dressing. It is intended to be used continuously over a prescribed period, being discarded and replaced along with the dressing as required. This is a single-use 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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: 2b6cae7a-8789-4c9d-be31-181d0eaa7412
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: March 01, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status
05060371000202	24	05060371000165	In Commercial Distribution
05060371000196	6	05060371000165	In Commercial Distribution
05060371000189	1	05060371000165	In Commercial Distribution