Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00810147400546
• Version / Model: CMC42520
• Catalog Number: CMC42520
• 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: eac345ce-f262-4dcf-9f60-64b4d112b6f8

Device Description

Areza Carboxymethyl Cellulose (CMC) Gelling Fiber is a primary wound dressing made from medical-grade sodium carboxymethyl cellulose (CMC). The pad/dressing turns into a hydrophilic gel as it comes into contact with wound fluid (exudate). The newly formed gel is soft and provides an optimal moist wound healing environment, can conform to the wound bed, and by loosening the non-live material over the wound (autolytic debridement) reduces the need for physical debridement. Areza CMC gelling fiber absorbs the wound fluid in a very unique vertical direction called "vertical absorbency", a capability that may reduce the risk of maceration by reducing the horizontal spread of the wound fluid to the other parts of the dressing. This dressing is ideal for moderate to highly leaking (exuding) wounds. CMC also reduces the risk of infection by creating a physical barrier to external contaminants and microscopic organisms. The non-adhesive formed gel reduces the risk of wound trauma during dressing changes.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43186	Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, 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	00850021481599	GS1
Primary	00810147400546	GS1
Package	00810147400775	GS1	Inner case	10	In Commercial Distribution
Package	00810147400782	GS1	Case	20	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4.25	Inch
Width	4.25	Inch

Storage Conditions

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