Widex

Basic Information

• Brand Name: Widex
• Primary DI: 05706069342192
• Version / Model: BB4
• Catalog Number: 8 251 0103 084
• Company Name: Widex A/S
• Labeler DUNS: 309843613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: 47d2c859-a4a6-448d-a098-5b9b9b82d343

Device Description

WIDEX BABY440 BTE (Pearl pink ) RC coil

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
ESD	Hearing Aid, Air Conduction	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56736	Air-conduction hearing aid, receiver-in-the-ear	A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone or microphones and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the outer ear [receiver-in-the-ear (RITE)]. The microphone(s) 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. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05706069342192	GS1

Customer Contacts

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