Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00810147401307
• Version / Model: TF12810
• Catalog Number: TF12810
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-10-11
• Public Version: 1
• Public Version Date: 2024-10-21
• Public Version Status: New
• Public Device Record Key: 39eb8e19-9282-4a03-93bf-b6d6e085c052

Device Description

Transparent Adhesive Film Dressing - 12" x 8" (10) consists of a thin polyurethane (PU) film, with a hypoallergenic, latex-free,adhesive that gently, yet securely, adheres to the skin. They are breathable, sterile, transparent, and water-resistant. It may beused as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to externalcontaminants.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58301	Synthetic polymer semi-permeable film dressing, adhesive	A transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810147401314	GS1	Inner case	10	In Commercial Distribution
Primary	00810147401307	GS1
Package	00810147401321	GS1	Case	20	In Commercial Distribution
Unit of Use	00810147401260	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	12	Inch
Width	8	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool, dry place. Avoid excessive heat