ELEHEAR Alpha

Basic Information

• Brand Name: ELEHEAR Alpha
• Primary DI: 69743465514172
• Version / Model: RIC 02
• Company Name: Elevoc Technology Co.,Ltd.
• Labeler DUNS: 544581147
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2023-09-30
• Public Version: 1
• Public Version Date: 2023-10-09
• Public Version Status: New
• Public Device Record Key: 5b979826-ae57-4b0a-943e-665e37e45f5e

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30082	Air-conduction hearing aid, wearable case	A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn on the body (e.g., in a pocket or on a belt). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould connected to the case by a cord. Because it's relatively large size permits high amplification, this device has been used for profound hearing loss; it has largely been replaced with behind-the-ear (BTE) devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06974346551417	GS1
Primary	69743465514172	GS1
Package	69743465502193	GS1		20	In Commercial Distribution

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 45 Degrees Celsius