FDA.reportPublic FDA data

Widex

Primary DI
05706069972078
Brand
Widex
Company
Widex A/S
Model
MBB2 220
Catalog number
8 411 0120 123
Device description
WIDEX MOMENT MBB2 220 (Autumn beige)
Published
2021-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05706069972078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05706069972078057060699720785706069972078

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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 behind-the-ear (BTE). 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 that fits inside the outer ear or a tube in the ear canal. 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544355600widex@widex.com

Regulatory Flags#

DUNS number
309843613
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880292077WidexALLURE ARRD2 440210488562026-05-22
05714880292084WidexALLURE ARRD2 440210488552026-05-22
05714880292091WidexALLURE ARRD2 440210488542026-05-22
05714880292107WidexALLURE ARRD2 440210488532026-05-22
05714880292114WidexALLURE ARRD2 440210488522026-05-22
05714880292121WidexALLURE ARRD2 440210488512026-05-22
05714880292138WidexALLURE ARRD2 440210488502026-05-22
05714880292145WidexALLURE ARRD2 440210488492026-05-22
05714880292152WidexALLURE ARRD2 440210488482026-05-22
05714880292169WidexALLURE ARRD2 440210488472026-05-22
05714880292176WidexALLURE ARRD2 330210488462026-05-22
05714880292183WidexALLURE ARRD2 330210488452026-05-22
05714880292190WidexALLURE ARRD2 330210488442026-05-22
05714880292206WidexALLURE ARRD2 330210488432026-05-22
05714880292213WidexALLURE ARRD2 330210488422026-05-22
05714880292220WidexALLURE ARRD2 330210488412026-05-22
05714880292237WidexALLURE ARRD2 330210488402026-05-22
05714880292244WidexALLURE ARRD2 330210488392026-05-22
05714880292251WidexALLURE ARRD2 330210488382026-05-22
05714880292268WidexALLURE ARRD2 330210488372026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880288117SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288124SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288131SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288148SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288155CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288162CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288179CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288186CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297508SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297515CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297522CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297539CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297546CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297553SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297560SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297577SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297928SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297935SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297942SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297959SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297966CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297973CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297980CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297997CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.OSM2026-06-08