FDA.report

GN Hearing

Primary DI
05708296228713
Brand
GN Hearing
Company
Gn Hearing A/S
Model
21398591
Device description
CHARGER,C-5,JABRA,BGE
Published
2022-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
QDDSelf-fitting air-conduction hearing aid
QUHSelf-fitting Air-Conduction Hearing Aid, Over the Counter

Product Code Classifications

CodeDeviceSpecialtyClass
QDDSelf-Fitting Air-Conduction Hearing Aid, PrescriptionEar, Nose, Throat2
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708296228713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708296228713057082962287135708296228713

GMDN Terms

TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods

Method

Contacts

PhoneEmail
+1-888-735-4327consumerhelp@gnresound.com

Regulatory Flags

DUNS number
306179227
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
05708296390243GN Hearing237709002026-03-05
05708296390328GN Hearing237717002026-03-05
05708296390410GN Hearing237726002026-03-05
05708296429073GN HearingJEC1CIC-HP2026-03-05
05708296429080GN HearingJEC1CIC-LP2026-03-05
05708296429097GN HearingJEC1CIC-MP2026-03-05
05708296429103GN HearingJEC1ITC-C-HP2026-03-05
05708296429110GN HearingJEC1ITC-C-LP2026-03-05
05708296429127GN HearingJEC1ITC-C-MP2026-03-05
05708296429134GN HearingJEC1ITC-C-UP2026-03-05
05708296429141GN HearingJEC1ITC-HP2026-03-05
05708296429158GN HearingJEC1ITC-LP2026-03-05
05708296429165GN HearingJEC1ITC-MP2026-03-05
05708296429172GN HearingJEC1ITC-UP2026-03-05
05708296429189GN HearingJEC1ITE-C-HP2026-03-05
05708296429196GN HearingJEC1ITE-C-MP2026-03-05
05708296429202GN HearingJEC1ITE-C-UP2026-03-05
05708296382927BeltoneILU17CIC-HP2026-02-10
05708296382934BeltoneILU17CIC-LP2026-02-10
05708296382941BeltoneILU17CIC-MP2026-02-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06971094538561HARMONIXHuizhou Jinghao Medical Technology Co., LtdQUH2026-01-20
00810153660811Lexie HearingHEARX GROUP (PTY) LTDQUH2025-07-31
00850010429304Eargo 8Eargo, Inc.QUH2025-05-13
00850010429328Eargo 8Eargo, Inc.QUH2025-05-13
00850010429540Eargo 8Eargo, Inc.QUH2025-05-13
00850010429687Eargo 8Eargo, Inc.QUH2025-05-13
00850010429694Eargo 8Eargo, Inc.QUH2025-05-13
00850010429700Eargo 8Eargo, Inc.QUH2025-05-13
00850010429717Eargo 8Eargo, Inc.QUH2025-05-13
00850010429724Eargo 8Eargo, Inc.QUH2025-05-13
00850010429793Eargo 8Eargo, Inc.QUH2025-05-13
00850010429809Eargo 8Eargo, Inc.QUH2025-05-13
00046838505065JVCNovidan, Inc.QUH2025-05-07
00850010429816Eargo SEEargo, Inc.QUH2025-04-07
00850010429731Eargo SEEargo, Inc.QUH2025-04-03
00850010429748Eargo SEEargo, Inc.QUH2025-04-03
00850010429755Eargo SEEargo, Inc.QUH2025-04-03
00850010429762Eargo SEEargo, Inc.QUH2025-04-03
16971094538094OXILINEHuizhou Jinghao Medical Technology Co., LtdQUH2025-03-24
16971094537998AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2025-02-25
10860010331030CeretoneAudicon CorporationQUH2024-09-04
16971094537790RETEKESSHuizhou Jinghao Medical Technology Co., LtdQUH2024-09-02
16971094537745AudialnetHuizhou Jinghao Medical Technology Co., LtdQUH2024-08-14
05714880227154SonyWs Audiology Usa, Inc.QUH2024-07-18
16971094537684HEARITEHuizhou Jinghao Medical Technology Co., LtdQUH2024-07-17
05714880215144SonyWs Audiology Usa, Inc.QUH2024-07-01
05714880215151SonyWs Audiology Usa, Inc.QUH2024-07-01
00850010429205Eargo RXEargo, Inc.QDD2024-06-17
00850010429274Eargo RXEargo, Inc.QDD2024-06-17
00850016231000Sontro Self-Fitting OTC Hearing AidsSoundwave Hearing, LLCQUH2024-05-07