Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00850021481230
• Version / Model: TF4X550
• Catalog Number: TF4X550
• Company Name: ADVANCED MEDICAL ASSOCIATES, LLC
• Labeler DUNS: 047724226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• 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: dc7afc8d-f239-442e-9304-205e4cbc42da

Device Description

Showerproof Transparent Adhesive Film 4" x 4.7" consist of a thin polyurethane (PU) film, with a hypoallergenic, latex-free, adhesive that gently, yet securely, adheres to the skin. They are breathable, sterile, transparent, and waterproof. May be used as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to external contaminants.

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	00850021481247	GS1
Primary	00850021481230	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4	Inch
Width	4.7	Inch

Storage Conditions

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