FDA.reportPublic FDA data

YI ANG

Primary DI
00850044211289
Brand
YI ANG
Company
Jiangxi Yi Ang Medical Technology Co., Ltd
Model
HAR705
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
00850044211289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044211289008500442112898500442112890850044211289

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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

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
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
00850044211395YI ANGHAN3072022-08-15
00850044211401YI ANGHAN3082022-08-15
00850044211418YI ANGHAN3092022-08-15
00850044211425YI ANGHAN3102022-08-15
00850044211432YI ANGHAT6212022-08-15
00850044211449YI ANGHAT6222022-08-15

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Primary DI, Brand, Company table
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