MIRACLE EAR

Basic Information

• Brand Name: MIRACLE EAR
• Primary DI: 05714880155785
• Version / Model: MECHARGE Custom v1
• Catalog Number: 21013249
• Company Name: Ws Audiology Usa, Inc.
• Labeler DUNS: 157412271
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-07
• Public Version: 1
• Public Version Date: 2024-03-15
• Public Version Status: New
• Public Device Record Key: f1c56339-3c6c-419f-8e68-e2048dd7d639

Device Description

ACC. MECHARGE CUSTOM V1

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
OSM	Hearing Aid, Air Conduction With Wireless Technology	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05714880155785	GS1

Customer Contacts

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