Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00850021481759
• Version / Model: AGF42520
• Catalog Number: AGF42520
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2024-10-26
• Public Version: 1
• Public Version Date: 2024-11-04
• Public Version Status: New
• Public Device Record Key: 339a4acf-ea7d-42fb-9fad-5f3ab2991c69

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 a 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
Package	00850021481827	GS1	Inner case	8	In Commercial Distribution
Primary	00850021481759	GS1
Package	00850021481834	GS1	Case	16	In Commercial Distribution
Unit of Use	00850021481346	GS1

Customer Contacts

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

Device Sizes

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

Storage Conditions

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