FDA.reportPublic FDA data

Bernafon

Primary DI
05711584095058
Brand
Bernafon
Company
Bernafon AG
Model
196561
Device description
VN5 MNR T, 2.4G NFM DPB MSIL VIRON 5
Published
2019-02-20
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
05711584095058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711584095058057115840950585711584095058

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
Premarket 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
06974608620523PHONELUMShenzhen Eartech Co., Ltd.OSM2026-08-27
05708296400942GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400959GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400966GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400973GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400980GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400997GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401000GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401017GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401024GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401031GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401048GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401055GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401062GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401079GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401086GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401093GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401109GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401116GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401123GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401130GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401550GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435265GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435272GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435289GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435296GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435302GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435319GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435326GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435333GN ReSoundGn Hearing A/SOSM2026-08-21