FDA.report

Bernafon

Primary DI
05711584084809
Brand
Bernafon
Company
Bernafon AG
Model
187795
Device description
CAPTO 5 FW 2.0
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KLWMasker, tinnitus

Product Code Classifications

CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05711584084809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05711584084809057115840848095711584084809

GMDN Terms

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

Contacts

PhoneEmail
+4539177100hama@oticon.com

Regulatory Flags

DUNS number
480002286
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05711584106570Bernafon2045432019-08-22
05711584106587Bernafon2045442019-08-22
05711584106549Bernafon2045402019-08-22
05711584106556Bernafon2045412019-08-22
05711584106563Bernafon2045422019-08-22
05714464006939Bernafon2220712020-12-17
05714464006946Bernafon2220832020-12-17
05714464006953Bernafon2220932020-12-17
05714464006960Bernafon2220982020-12-17
05714464006977Bernafon2221032020-12-17
05714464006984Bernafon2221082020-12-17
05714464008926Bernafon2220612020-12-17
05714464008933Bernafon2220622020-12-17
05714464008940Bernafon2220632020-12-17
05714464008957Bernafon2220642020-12-17
05714464008964Bernafon2220652020-12-17
05714464008971Bernafon2220662020-12-17
05714464008988Bernafon2220672020-12-17
05714464008995Bernafon2220682020-12-17
05714464009008Bernafon2220692020-12-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613389834147Phonak Audéo E90-Sphere Sonova AGKLW2026-03-17
07613389860498Phonak Audéo E30-Sphere Sonova AGKLW2026-03-17
07613389891171Phonak Audéo E90-RSonova AGKLW2026-03-16
05714464175529BernafonSbo Hearing A/SKLW2026-02-25
05714464175567NeutralSbo Hearing A/SKLW2026-02-25
05714464175598PhilipsSbo Hearing A/SKLW2026-02-25
05714464175628OticonSbo Hearing A/SKLW2026-02-25
05714464176151PhilipsSbo Hearing A/SKLW2026-02-25
05714464176168PhilipsSbo Hearing A/SKLW2026-02-25
05714464176335OticonSbo Hearing A/SKLW2026-02-25
05714464176359OticonSbo Hearing A/SKLW2026-02-25
05714464182848OticonSbo Hearing A/SKLW2026-02-25
05714464182855OticonSbo Hearing A/SKLW2026-02-25
05714464182879OticonSbo Hearing A/SKLW2026-02-25
05714464182893OticonSbo Hearing A/SKLW2026-02-25
05714464182916OticonSbo Hearing A/SKLW2026-02-25
05714464182985OticonSbo Hearing A/SKLW2026-02-25
05714464183005OticonSbo Hearing A/SKLW2026-02-25
05714464183050OticonSbo Hearing A/SKLW2026-02-25
05714464183074OticonSbo Hearing A/SKLW2026-02-25
05714464183081OticonSbo Hearing A/SKLW2026-02-25
05714464183098OticonSbo Hearing A/SKLW2026-02-25
05714464183104OticonSbo Hearing A/SKLW2026-02-25
05714464183111OticonSbo Hearing A/SKLW2026-02-25
05714464183142OticonSbo Hearing A/SKLW2026-02-25
05714464183180OticonSbo Hearing A/SKLW2026-02-25
05714464183203OticonSbo Hearing A/SKLW2026-02-25
05714464183227OticonSbo Hearing A/SKLW2026-02-25
05714464183234OticonSbo Hearing A/SKLW2026-02-25
05714464183241OticonSbo Hearing A/SKLW2026-02-25