OxySpur® lite Oxygen Diffusion Dressings

Basic Information

• Brand Name: OxySpur® lite Oxygen Diffusion Dressings
• Primary DI: 00851404004121
• Version / Model: 2" x 10" Adhesive
• Catalog Number: 600015
• Company Name: Electrochemical Oxygen Concepts, Inc.
• Labeler DUNS: 948938092
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-24
• Public Version: 1
• Public Version Date: 2023-08-01
• Public Version Status: New
• Public Device Record Key: af9fbe93-fd91-457d-ae37-2f287521b616

Device Description

OxySpur® lite Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are constructed with a non-adherent mesh layer directly adjacent to the wound, one lite absorbent hydrophilic foam layer with channels for oxygen distribution, covered by an occlusive film, and an adhesive border. The OxySpur® lite is to be used on wounds with minimal to low exudate, such as later in the wound healing cycle when wound exudate levels decrease.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851404004121	GS1

Premarket Submissions

Submission Number	Supplement Number
K090681	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 86 Degrees Fahrenheit