FDA.reportPublic FDA data

Bernafon

Primary DI
05711584090305
Brand
Bernafon
Company
Bernafon AG
Model
190121
Device description
ZERENA 1 B 105 FW 3.0
Published
2018-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711584090305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711584090305057115840903055711584090305

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid wireless-fitting computer-aided setA collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100hama@oticon.com

Regulatory Flags#

DUNS number
480002286
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
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
05714880113778CONNEXXWs Audiology Usa, Inc.OSM2026-05-28
05714880214345Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214345Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28