FDA.reportPublic FDA data

Bernafon

Primary DI
05711584086148
Brand
Bernafon
Company
Bernafon AG
Model
191313
Device description
ZR1 MNR T, 2.4G NFM DPB SABE/MSIL DEMO ZERENA 1
Published
2018-08-20
Public version status
Update
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
05711584086148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711584086148057115840861485711584086148

GMDN Terms#

Term, Definition table
TermDefinition
Receiver-in-the-ear air-conduction hearing aidA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100hama@oticon.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
07613275596814PhonakSonova AGOSM2018-02-28
07613275596821PhonakSonova AGKLW2018-02-28
07613275596838PhonakSonova AGKLW2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596852PhonakSonova AGKLW2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596876PhonakSonova AGKLW2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596890PhonakSonova AGKLW2018-02-28
07613275596906PhonakSonova AGKLW2018-02-28
07613275596913PhonakSonova AGKLW2018-02-28
07613275596920PhonakSonova AGKLW2018-02-28
07613275596937PhonakSonova AGKLW2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596975PhonakSonova AGKLW2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597026PhonakSonova AGKLW2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601310PhonakSonova AGKLW2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601334PhonakSonova AGKLW2018-02-28
07613275601341PhonakSonova AGKLW2018-02-28
07613275601358PhonakSonova AGKLW2018-02-28
07613275601365PhonakSonova AGKLW2018-02-28
07613275601372PhonakSonova AGKLW2018-02-28