Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00850021481070
• Version / Model: FT2X102
• Catalog Number: FT2X102
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-10-25
• Public Version: 2
• Public Version Date: 2022-09-29
• Public Version Status: Update
• Public Device Record Key: 55968207-2ef3-4d4d-aee2-b2005074afab

Device Description

Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (2 Roll)is composed of a soft, porous, semi-occlusive fabric backing covered with an adhesive layer. Fabripore adhesive tape is designed to decrease the risk of maceration while securing other dressings (primary) over wounds, catheters, tubings, electrodes, and any other device items that may need fixation. Conveniently perforated every 2 inches to be able to tear it by hand for easier handling. No latex is used in production.

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10284	Pressure bandage, non-latex, single-use	A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850021481070	GS1
Unit of Use	00850021481605	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2	Inch
Length	10	Yard

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, cool place. Avoid excessive heat.