Areza Medical

Basic Information

• Brand Name: Areza Medical
• Primary DI: 00810147400225
• Version / Model: COPOVV10
• Catalog Number: COPOVV10
• 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: 61a8760f-e7fd-470c-9346-37b80cd06c3a

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62525	Intestinal ostomy bag/support kit	A collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810147400232	GS1	Inner case	10	In Commercial Distribution
Primary	00810147400225	GS1
Package	00810147400249	GS1	Case	30	In Commercial Distribution
Unit of Use	00810147400218	GS1

Customer Contacts

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

Storage Conditions

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