FDA.reportPublic FDA data

JIUYEE, Smart Bluetooth Hearing Aid (ITE)

Primary DI
06975925880140
Brand
JIUYEE, Smart Bluetooth Hearing Aid (ITE)
Company
Hunan JIUYEE Medical Technology Co., Ltd
Model
Air C2, Jade Gold
Published
2023-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975925880147PackageGS120In Commercial Distribution
06975925880140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697592588014716975925880147
06975925880140069759258801406975925880140

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Regulatory Flags#

DUNS number
699350218
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975925880164JlUYEE, Smart Bluetooth Hearing Aid (RlC)REAL P3,Obsidian Black2024-07-30
16975925880161JlUYEE, Smart Bluetooth Hearing Aid (RlC)REAL P3,Obsidian Black2024-07-30
06975925880133JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Emerald Black2023-07-30
06975925880157JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Pearl White2023-07-30
16975925880130JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Emerald Black2023-07-30
16975925880147JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Jade Gold2023-07-30
16975925880154JIUYEE, Smart Bluetooth Hearing Aid (ITE) Air C2, Pearl White2023-07-30
06975925880058JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Emerald Black2023-02-03
06975925880065JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Jade White2023-02-03
06975925880072JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P4, Emerald Black2023-02-02
06975925880089JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P4, Jade White2023-02-03
06975925880096JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Emerald Black, Left2023-04-17
06975925880102JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Emerald Black, Right2023-04-17
06975925880119JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Jade White, Left2023-04-17
06975925880126JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Jade White, Right2023-04-17
06975925880010JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P1, Emerald Black2023-02-03
06975925880027JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P1, Jade White2023-02-03
06975925880034JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P2, Emerald Black2023-02-03
06975925880041JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P2, Jade White2023-02-03
16975925880055JIUYEE, Smart Bluetooth Hearing Aid (RIC) REAL P3, Emerald Black2023-02-03

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