Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00850021481056
• Version / Model: 44220
• Catalog Number: 44220
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-10-27
• Public Version: 1
• Public Version Date: 2020-11-04
• Public Version Status: New
• Public Device Record Key: f41ad0fe-bf03-41e5-93d9-c665c74d5a10

Device Description

Areza Silicone Foam Dressing for Ostomies consists of a fenestrated, self-adhering, silicone wound contact layer, an absorbent polyurethane (PU) foam pad layer, and a vapor permeable and waterproof polyurethane film backing. The triple-layer construction facilitates dynamic fluid management to provide optimal moist wound environment; and may help reduce the risk of maceration. The absorbent pad layer provides superior absorption locking away exudates.

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
Primary	00850021481056	GS1
Unit of Use	00850021481223	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Circumference	23.88	Centimeter

Storage Conditions

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