AccessGUDID - DEVICE: OxySpur® Oxygen Diffusion Dressing (00851404004022)

GUDID

Device Identifier (DI) Information

Brand Name: OxySpur® Oxygen Diffusion Dressing
Version or Model: 2" x 2" Non-Adhesive
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 600011
Company Name: Electrochemical Oxygen Concepts, Inc.

Primary DI Number: 00851404004022
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?
62348	Wound therapy oxygenator dressing	A sterile wound cover designed to be used in conjunction with a wound therapy oxygenator to actively promote continuous diffusion of oxygen (CDO) in a wound bed to heal various types of wounds (e.g., arterial, venous, diabetic or pressure ulcers, skin grafts, burns, and/or postoperative or traumatic wounds). It is made of synthetic polymer materials and consists of an absorbent open-cell foam layer, an oxygen (O2) distribution foam layer, an occlusive layer to create an O2 rich environment, and integrated O2 tubing/connector. It may have an adhesive border and may be cut to conform to the wound. O2 delivery extension tubing may be included. 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 [?]
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: 1cb07a7f-7546-4618-9def-b2adf2e603a8
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023