FDA.reportPublic FDA data

YI ANG

Primary DI
00850044211388
Brand
YI ANG
Company
Jiangxi Yi Ang Medical Technology Co., Ltd
Model
HAN306
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
00850044211388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044211388008500442113888500442113880850044211388

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
Donation ID 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
00850044211395YI ANGHAN3072022-08-15
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
05714880279566SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880279573SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880293470SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880293487SigniaWs Audiology Usa, Inc.OSM2026-05-27
07613275596814PhonakSonova AGOSM2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601402PhonakSonova AGOSM2018-02-28
07613275601426PhonakSonova AGOSM2018-02-28
07613275601501PhonakSonova AGOSM2018-02-28
07613275601518PhonakSonova AGOSM2018-02-28
07613275601556PhonakSonova AGOSM2018-02-28
07613275601594PhonakSonova AGOSM2018-02-28
07613275601600PhonakSonova AGOSM2018-02-28
07613275601655PhonakSonova AGOSM2018-02-28
07613275601662PhonakSonova AGOSM2018-02-28
07613275601686PhonakSonova AGOSM2018-02-28
07613275601693PhonakSonova AGOSM2018-02-28
07613275602935PhonakSonova AGOSM2018-02-28
07613275602959PhonakSonova AGOSM2018-02-28