Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077212394
• Version / Model: CB 500
• Catalog Number: CB 500
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2021-12-03
• Public Version: 2
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 86697c40-2c0f-4997-bba1-ee21047ed42f

Device Description

Medium Cotton Balls 500

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRL	FIBER, MEDICAL, ABSORBENT	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63281	Cotton wool ball	A non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical setting. 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	00810077212479	GS1
Primary	00810077212394	GS1

Customer Contacts

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