Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00850021481315
• Version / Model: 45332
• Catalog Number: 45332
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-10-26
• Public Version: 1
• Public Version Date: 2020-11-03
• Public Version Status: New
• Public Device Record Key: 627a9b02-1e0c-4826-9d1f-6ee0863b00a8

Device Description

Foam dressings are sheets of foamed polymer solutions (most commonly polyurethane) with small, open cells capable of holding fluids. They are layered in combination with other materials. Absorption capability depends on thickness and composition. The area in contact with the wound surface is non-adhesive for easy removal. Available with an adhesive border and/or a transparent film coating that acts as a bacterial barrier. Indicated for 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	00850021481315	GS1

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 dry, cool environment. Avoid excessive heat.