Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077213476
• Version / Model: tri-ban12
• Catalog Number: tri-ban12
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-03-23
• Public Version: 2
• Public Version Date: 2022-06-29
• Public Version Status: Update
• Public Device Record Key: 851715fd-852b-4bd9-9155-7d64f5a1d1b5

Device Description

Triangular Bandages 40" x 40" x 56" x36

Device Characteristics

• Single Use: No
• 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
NEC	Bandage, liquid, skin protectant	General Hospital	880.5090	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62041	First aid limb splint, non-mouldable, single-use	A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It consists of an unpadded, non-mouldable rigid portion which is applied externally to the limb and held in place with straps/ropes, and may be capable or applying traction; it is made of a variety of materials, and may be used in the home or by emergency medical services (EMS). 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	00810077213513	GS1
Primary	00810077213476	GS1
Previous	00667605028268	GS1

Customer Contacts

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