FDA.reportPublic FDA data

Bernafon

Primary DI
05711584106563
Brand
Bernafon
Company
Bernafon AG
Model
204542
Device description
OASIS NXT 2019.2 CUSTOM
Published
2019-08-22
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
05711584106563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711584106563057115841065635711584106563

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
480002286
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
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
05714880270303WidexWidex A/SOSM2026-10-22
05708296447022GN HearingGn Hearing A/SOSM2026-10-21
05708296474998GN HearingGn Hearing A/SOSM2026-10-21
05708296475001GN HearingGn Hearing A/SOSM2026-10-21
05708296475025GN HearingGn Hearing A/SOSM2026-10-21
05708296475032GN HearingGn Hearing A/SOSM2026-10-21
05708296475049GN HearingGn Hearing A/SOSM2026-10-21
05708296485369GN HearingGn Hearing A/SOSM2026-10-21
05708296485529GN HearingGn Hearing A/SOSM2026-10-21
05708296249787BeltoneGn Hearing A/SKLW2022-08-24
05708296249787BeltoneGn Hearing A/SOSM2022-08-24
05708296249978BeltoneGn Hearing A/SOSM2022-08-24
05708296249978BeltoneGn Hearing A/SKLW2022-08-24
05708296226856GN HearingGn Hearing A/SKLW2021-06-11
05708296226856GN HearingGn Hearing A/SOSM2021-06-11
05708296226863GN HearingGn Hearing A/SOSM2021-06-11
05708296226863GN HearingGn Hearing A/SKLW2021-06-11
05708296227099GN HearingGn Hearing A/SOSM2021-06-11
05708296227099GN HearingGn Hearing A/SKLW2021-06-11
05708296220724GN HearingGn Hearing A/SKLW2021-06-07
05708296220724GN HearingGn Hearing A/SOSM2021-06-07
05708296221233GN HearingGn Hearing A/SOSM2021-06-07
05708296221233GN HearingGn Hearing A/SKLW2021-06-07
05708296221257GN HearingGn Hearing A/SKLW2021-06-07
05708296221257GN HearingGn Hearing A/SOSM2021-06-07
05708296221325GN HearingGn Hearing A/SKLW2021-06-07
05708296221325GN HearingGn Hearing A/SOSM2021-06-07
05708296221394GN HearingGn Hearing A/SKLW2021-06-07
05708296221394GN HearingGn Hearing A/SOSM2021-06-07
05708296221400GN HearingGn Hearing A/SKLW2021-06-07