REAL-EAR

Basic Information

• Brand Name: REAL-EAR
• Primary DI: 05711781000091
• Version / Model: REAL-EAR CLIENT RESPONSE
• Catalog Number: 10823942
• Company Name: Ws Audiology Usa, Inc.
• Labeler DUNS: 157412271
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-22
• Public Version: 4
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 0ca9183b-8f33-4a49-b9a7-be5cc8ac156f

Device Description

REAL-EAR CLIENT RESPONSE

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: No
• Has Lot/Batch Number: No
• 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
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45241	Audiometric/hearing aid tester	An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05711781000091	GS1

Customer Contacts

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