Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00850021481643
• Version / Model: ST15502
• Catalog Number: ST15502
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-06-22
• Public Version: 1
• Public Version Date: 2024-07-01
• Public Version Status: New
• Public Device Record Key: a3e63551-3a38-473a-9094-285d84f0e1de

Device Description

AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoallergenic nature and ease of removal make it an ideal tape for patients with fragile skin or sensitivity to acrylic adhesives. Areza Silicone Tape consists of a polyurethane film carrier (backing) and a potent adhesive silicone gel. The combination of strong adhesion and skin-friendliness makes this tape ideal for applications requiring a secure hold without causing skin irritation. This tape finds versatile applications in various healthcare settings and conditions, providing extended wear time. It is commonly used in wound care, post-surgery recovery, and medical device fixation, among other healthcare applications.

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
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810147400171	GS1	Inner case	6	In Commercial Distribution
Primary	00850021481643	GS1
Package	00810147400188	GS1	Case	72	In Commercial Distribution
Unit of Use	00810147400119	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	5.46	Yard
Width	1	Inch

Storage Conditions

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