Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810124530853
• Version / Model: VKEBS
• Catalog Number: VKEBS
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-11-22
• Public Version: 1
• Public Version Date: 2023-11-30
• Public Version Status: New
• Public Device Record Key: 1d920cf5-bd06-4921-98ef-87275b7d1153

Device Description

Ear Suction Ulcer Bulb - Sterile 2oz

Device Characteristics

• Single Use: No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYH	EXCAVATOR, EAR	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35025	Ear canal irrigation syringe	A device intended to be used to flush the ear canal with an irrigating solution. It is typically available in two main design mechanisms that are used to carefully exert pressure on the irrigating fluid: 1) a cylindrical barrel with a plunger that have finger and thumb rings respectively mounted onto them for the operator to apply the necessary pressure; and 2) an elastomeric rubber, one-piece bulb that tapers to a thin nozzle that fits into the outer ear canal. This device may be used by a healthcare professional or by the patient/end user. 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	00810124530976	GS1
Primary	00810124530853	GS1

Customer Contacts

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