AccessGUDID - DEVICE: OxySpur® Oxygen Diffusion Dressing (00851404004046)

GUDID

Device Identifier (DI) Information

Brand Name: OxySpur® Oxygen Diffusion Dressing
Version or Model: 4" x 5" Non-Adhesive
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 600013
Company Name: Electrochemical Oxygen Concepts, Inc.

Primary DI Number: 00851404004046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 948938092 *Terms of Use

Device Description: OxySpur® Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are a multi-layer construct with a highly absorbent hydrophilic foam layer directly adjacent to the wound, a highly absorbent hydrophilic foam layer with channels for oxygen distribution, and a super absorbent polymeric laminate, all of which are covered by an occlusive film.

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 [?]
K090681	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
Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1244b95-722b-4eaf-8257-a8aee2bc3ca9
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023