Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00850021481339
• Version / Model: AGF4255
• Catalog Number: AGF4255
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2021-03-22
• Public Version: 1
• Public Version Date: 2021-03-30
• Public Version Status: New
• Public Device Record Key: 36b1b614-e5c8-4441-8e1f-9a8f24cf9f0e

Device Description

Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic silver particles. The dressing contains 0.35~0.40mg/cm3 (17.3~20.1 mg/100cm2) of ionic silver. The high absorbency, along with antibacterial properties, qualify Areza Medical Silver Foam Dressing as a very useful dressing indicated for exudate absorption and the management of partial to full thickness wounds. The dressing provides proper moist wound healing environment.

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: 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
48124	Exudate-absorbent dressing, non-gel, antimicrobial	A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850021481346	GS1
Primary	00850021481339	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	4.25	Inch
Length	4.25	Inch
Height	5	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature, avoid extreme heat.