FDA.reportPublic FDA data

YI ANG

Primary DI
00850044211395
Brand
YI ANG
Company
Jiangxi Yi Ang Medical Technology Co., Ltd
Model
HAN307
Published
2022-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850044211395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044211395008500442113958500442113950850044211395

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid neck induction loop, wireless inputA portable, battery-powered device worn around the neck intended to receive sound from an audio source [e.g., mobile (cellular) telephone] wirelessly (e.g., via Bluetooth) and transfer it via an audio frequency magnetic field to a hearing aid with an induction coil (i.e., bypassing the hearing aids microphone) when it is switched to the "T" or `?MT?? position, in order for the hearing aid user to hear (e.g., telephone conversation, music) more clearly. It typically consists of small active amplifier with a wire loop worn around the neck. It may also include a microphone for hands-free telephone conversation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
699488533
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044211241YI ANGHAT60182022-08-15
00850044211258YI ANGHAR7012022-08-15
00850044211265YI ANGHAR7022022-08-15
00850044211272YI ANGHAR7032022-08-15
00850044211289YI ANGHAR7052022-08-15
00850044211296YI ANGHAR7062022-08-15
00850044211302YI ANGHAR7072022-08-15
00850044211319YI ANGHAR7082022-08-15
00850044211326YI ANGHAR7092022-08-15
00850044211333YI ANGHAR7102022-08-15
00850044211340YI ANGHAN3012022-08-15
00850044211357YI ANGHAN3022022-08-15
00850044211364YI ANGHAN3032022-08-15
00850044211371YI ANGHAN3052022-08-15
00850044211388YI ANGHAN3062022-08-15
00850044211401YI ANGHAN3082022-08-15
00850044211418YI ANGHAN3092022-08-15
00850044211425YI ANGHAN3102022-08-15
00850044211432YI ANGHAT6212022-08-15
00850044211449YI ANGHAT6222022-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05714880299564REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299571REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299588REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299595REXTONWs Audiology Usa, Inc.OSM2026-10-28
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05714880299618REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299625REXTONWs Audiology Usa, Inc.OSM2026-10-28
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05714880299649REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299656REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299663REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299670REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299687REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299694REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299991MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300000MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300017MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300024MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300031MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300048MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300055MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300062MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
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05714880300086MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300093MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300109MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27