Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077213278
• Version / Model: 3436Rx10+vig
• Catalog Number: 3436Rx10+vig
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-03-22
• Public Version: 2
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: 73ce8b40-405d-451b-b677-f2b1bff6770b

Device Description

Washable Underpads 34"x36" x10

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
66117	Absorbent underpad, non-antimicrobial, reusable	A flat piece of absorbent fabric material (e.g., polyester, cotton) intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence); it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810077214220	GS1
Primary	00810077213278	GS1
Previous	00667605029937	GS1

Customer Contacts

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