Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077211168
• Version / Model: 2022A x12+st
• Catalog Number: 2022A x12+st
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 168
• Record Status: Published
• Publish Date: 2021-12-03
• Public Version: 2
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: 55c4ab9c-050d-4bdf-a21e-08d7e004f8f6

Device Description

Maximum Absorbency Maternity Pads 168

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
HHD	Pad, menstrual, unscented	Obstetrics/Gynecology	884.5435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40545	Menstrual pad, unscented	A non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. 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	00810077212424	GS1
Primary	00810077211168	GS1

Customer Contacts

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