Jacoti Hearing Center

Basic Information

• Brand Name: Jacoti Hearing Center
• Primary DI: 05407004250021
• Version / Model: Jacoti Hearing Center 1.X
• Company Name: Jacoti
• Labeler DUNS: 762560282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-09
• Public Version: 1
• Public Version Date: 2023-01-17
• Public Version Status: New
• Public Device Record Key: 0b72a976-8db3-4f81-a228-1dbf2abecb31

Device Description

Jacoti Hearing Center 1.X

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWO	AUDIOMETER	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46964	Self-testing tone audiometer	A battery-powered electroacoustic device that is designed for self-testing by the user to qualitatively evaluate hearing acuity by presenting a series of tones at a fixed level. It is placed over the user's ear and a microprocessor [central processing unit (CPU)] in the device automatically produces a range of tones at pre-set decibel (dB) levels. If the user cannot hear all of the tones then this may be an indication of diminished hearing acuity and the need for formal audiological assessment. This device is available [non-prescription] over-the-counter (OTC) and is typically used in the home or a general practitioner's office.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05407004250021	GS1

Customer Contacts

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