FDA.reportPublic FDA data

Braun

Primary DI
00328785002911
Brand
Braun
Company
KAZ USA, INC.
Model
BHA101F
Device description
UPC/UDI BRAUN HEARING AID SINGLE DEVICE CHAMPAGNE (Contains unit of use 10328785002901)
Published
2022-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDDSelf-Fitting Air-Conduction Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDDSelf-Fitting Air-Conduction Hearing Aid, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00328785002911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00328785002911003287850029113287850029110328785002911

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA 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 and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone 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
1-800-477-0457consumerrelations@kaz.com

Regulatory Flags#

DUNS number
122612547
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00328785014303BRAUNBUA4000BUS2025-09-19
00328785000160SoftheatHP910V12019-09-04
00092926503208HoneywellHEV320B2018-03-30
00328785001334HONEYWELLHWM845B2018-08-01
00328785001723HONEYWELLHUL430W2018-08-01
00328785002362HONEYWELLHWC775B2021-09-30
00328785004083HoneywellHWM440W2020-08-17
00328785004113HoneywellHWM440B2020-08-17
00328785006247HoneywellHWC775W2021-09-30
00328785006537HoneywellHUL525B2021-10-15
00328785006544HoneywellHUL525W2021-10-15
00328785006575HoneywellHUL545B2021-10-15
00328785006612HoneywellHUL545W2021-10-15
00328785006629HoneywellHUL5302021-10-15
00328785006636HoneywellHUL565B2021-10-15
00328785004106HoneywellHWM445B2020-08-17
00328785000054BraunIRT6500US2016-09-09
00328785000092Braun IRT6020USIRT6020US2016-09-09
00328785000276VicksV912USV12016-11-04
00328785000450Kaz821-242016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010429205Eargo RXEargo, Inc.QDD2024-06-17
00850010429274Eargo RXEargo, Inc.QDD2024-06-17
05708296231010GN HearingGn Hearing A/SQDD2024-04-12
05708296231027GN HearingGn Hearing A/SQDD2024-04-12
05708296231034GN HearingGn Hearing A/SQDD2024-04-12
05708296231041GN HearingGn Hearing A/SQDD2024-04-12
05708296237944GN HearingGn Hearing A/SQDD2024-04-12
05708296237951GN HearingGn Hearing A/SQDD2024-04-12
05708296237968GN HearingGn Hearing A/SQDD2024-04-12
05708296237975GN HearingGn Hearing A/SQDD2024-04-12
05714880182781SonyWs Audiology Usa, Inc.QDD2023-05-30
05714880182750SonyWs Audiology Usa, Inc.QDD2022-12-20
05708296260775GN HearingGn Hearing A/SQDD2022-12-08
05708296260782GN HearingGn Hearing A/SQDD2022-12-08
05708296260799GN HearingGn Hearing A/SQDD2022-12-08
00850022464645Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
00850022464577Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
10850022464642Lexie HearingHEARX GROUP (PTY) LTDQDD2022-10-05
05714880182743SonyWs Audiology Usa, Inc.QDD2022-09-12
00850022464638Lexie B2, Powered by BoseHEARX GROUP (PTY) LTDQDD2022-09-09
00850022464492Lexie B1, Powered by BoseHEARX GROUP (PTY) LTDQDD2022-08-01
05708296228706GN HearingGn Hearing A/SQDD2022-07-08
05708296228713GN HearingGn Hearing A/SQDD2022-07-08
05708296233656GN HearingGn Hearing A/SQDD2022-07-08
05708296237609GN HearingGn Hearing A/SQDD2022-07-08
05708296238040GN HearingGn Hearing A/SQDD2022-07-08
05708296238057GN HearingGn Hearing A/SQDD2022-07-08
05708296238064GN HearingGn Hearing A/SQDD2022-07-08
05708296238071GN HearingGn Hearing A/SQDD2022-07-08
05708296237883GN HearingGn Hearing A/SQDD2022-04-04