Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00850021481902
• Version / Model: F5410
• Catalog Number: F5410
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-10-26
• Public Version: 1
• Public Version Date: 2024-11-04
• Public Version Status: New
• Public Device Record Key: fb2e4d64-a10d-4a57-ad4c-fce19cbcee97

Device Description

Areza Foam Dressing is a sterile, disposable, soft, and highly absorbent foam dressing composed of polyurethane (PU) with a waterproof PU film backing, which may act as a physical barrier to infectious contaminants. Its design consists of small, open cells with a high absorptive capability making this dressing ideal for excessive exuding wounds. The dressing maintains a moist environment, ideal for wound healing, while also decreasing maceration to the surrounding, peri-wound, skin. The area in contact with the wound surface is non-adhesive for easy removal as long as the foam is moist. The part of the dressing that faces the wound has a small risk of adhering to wound surface if the wound is bleeding and/or has a low exudate. It is ideal to be used in partial and full-thickness wounds.

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
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850021481322	GS1
Primary	00850021481902	GS1
Package	00850021481926	GS1	Inner case	16	In Commercial Distribution
Package	00850021481933	GS1	Case	32	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	5	Inch
Width	4	Inch

Storage Conditions

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