OtoClear® Ear Irrigation System (220V)

Basic Information

• Brand Name: OtoClear® Ear Irrigation System (220V)
• Primary DI: 00714646000965
• Version / Model: OC-07247
• Catalog Number: 7247
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: ee686533-f59e-4387-84a5-1346a555e654

Device Description

OtoClear® Ear Irrigation System (220V)- 40 Tips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LRD	APPLICATOR, ENT DRUG	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46323	Ear canal lavage system	A device assembly designed for automated or semi-automated irrigation, washing, and extraction of tissue and/or debris from the ear canal. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a vacuum extractor, a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the ear canal. The system is mainly intended to remove debris (typically cerumen) to clean the ear canal for hygienic purposes, to improve hearing, and before procedures and/or surgery in or through the ear canal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00714646000965	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]