FDA.reportPublic FDA data

Bernafon

Primary DI
05711584114117
Brand
Bernafon
Company
Bernafon AG
Model
212673
Device description
AN3, BTE UP 2.4G NFM SABE DEMO ALTENA 3 GPL
Published
2020-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
05711584114117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711584114117057115841141175711584114117

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100eand@demant.com

Regulatory Flags#

DUNS number
480002286
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711584083321Bernafon1858912018-08-20
05711584083345Bernafon1858932018-08-20
05711584083352Bernafon1858942018-08-20
05711584083376Bernafon1858962018-08-20
05711584083482Bernafon1859982018-08-20
05711584083505Bernafon1860002018-08-20
05711584083512Bernafon1860012018-08-20
05711584083536Bernafon1860032018-08-20
05711584083642Bernafon1860502018-08-20
05711584083666Bernafon1860522018-08-20
05711584083673Bernafon1860532018-08-20
05711584083697Bernafon1860552018-08-20
05711584087060Bernafon1919862018-08-20
05711584087084Bernafon1919882018-08-20
05711584087091Bernafon1919892018-08-20
05711584087114Bernafon1919912018-08-20
05711584087527Bernafon1920322018-08-20
05711584087541Bernafon1920342018-08-20
05711584087558Bernafon1920352018-08-20
05711584087572Bernafon1920372018-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880288629WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880294392CONNEXXWs Audiology Usa, Inc.OSM2026-11-04
05714880297416WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880297881CONNEXXWs Audiology Usa, Inc.OSM2026-11-04
05714880300390WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880300116TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300123TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880296181WidexWidex A/SOSM2026-10-30
05714880296198WidexWidex A/SOSM2026-10-30
05714880296204WidexWidex A/SOSM2026-10-30
05714880296211WidexWidex A/SOSM2026-10-30
05714880296228WidexWidex A/SOSM2026-10-30
05714880296235WidexWidex A/SOSM2026-10-30
05714880296242WidexWidex A/SOSM2026-10-30
05714880296259WidexWidex A/SOSM2026-10-30
05714880296266WidexWidex A/SOSM2026-10-30
05714880296273WidexWidex A/SOSM2026-10-30
05714880296280WidexWidex A/SOSM2026-10-30
05714880296297WidexWidex A/SOSM2026-10-30
05714880296303WidexWidex A/SOSM2026-10-30
05714880296310WidexWidex A/SOSM2026-10-30
05714880296327WidexWidex A/SOSM2026-10-30
05714880296334WidexWidex A/SOSM2026-10-30
05714880296341WidexWidex A/SOSM2026-10-30
05714880296358WidexWidex A/SOSM2026-10-30
05714880296365WidexWidex A/SOSM2026-10-30
05714880296372WidexWidex A/SOSM2026-10-30
05714880296389WidexWidex A/SOSM2026-10-30