Oxyband

Basic Information

• Brand Name: Oxyband
• Primary DI: 00009235421772
• Version / Model: 1
• Company Name: The Lighthouse For The Blind
• Labeler DUNS: 051731214
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-05
• Public Version: 1
• Public Version Date: 2021-10-13
• Public Version Status: New
• Public Device Record Key: b78f53d6-2453-4fb1-b2d0-4bc49a49bb13

Device Description

Oxyband 4.5 X 5.5 Dressing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
FRO	Dressing, Wound, Drug	Unknown		U

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	00009235421772	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K043063	000