Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810124535162
• Version / Model: IBP3X11
• Catalog Number: IBP3X11
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2025-02-22
• Public Version: 1
• Public Version Date: 2025-03-03
• Public Version Status: New
• Public Device Record Key: f8caf88b-7d59-4d56-82e5-5244078b9d21

Device Description

Adult Incontinence Booster Pads [Large 3.5''x11.5'']

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYQ	GARMENT, PROTECTIVE, FOR INCONTINENCE	Gastroenterology, Urology	876.5920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35817	Incontinence pants liner	A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. 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	00810124535339	GS1
Primary	00810124535162	GS1

Customer Contacts

• Phone: [phone] ext. 204
• Email: [email protected]