JlUYEE, Smart Bluetooth Hearing Aid (RlC)

GUDID 16975925880161

The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell and receiver, and accessories, including the earplugs, cerumen baffle, charging box and charging cable. After inspection and fitting, the hearing aids is applicable for patients with air conduction hearing loss.

Hunan JIUYEE Medical Technology Co., Ltd

Air-conduction hearing aid, behind-the-ear
Primary Device ID16975925880161
NIH Device Record Keyf2a133c6-e833-4a1f-85e2-cb35cdc890da
Commercial Distribution StatusIn Commercial Distribution
Brand NameJlUYEE, Smart Bluetooth Hearing Aid (RlC)
Version Model NumberREAL P3,Obsidian Black
Company DUNS699350218
Company NameHunan JIUYEE Medical Technology Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106975925880164 [Primary]
GS116975925880161 [Package]
Contains: 06975925880164
Package: [10 Units]
In Commercial Distribution

FDA Product Code

QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-07
Device Publish Date2024-07-30

Devices Manufactured by Hunan JIUYEE Medical Technology Co., Ltd

16975925880161 - JlUYEE, Smart Bluetooth Hearing Aid (RlC)2024-08-07The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell and receiver, and accessories, including the earplugs, cerumen baffle, charging box and charging cable. After inspection and fitting, the hearing aids is applicable for patients with air conduction hearing loss.
16975925880161 - JlUYEE, Smart Bluetooth Hearing Aid (RlC)2024-08-07 The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell
16975925880130 - JIUYEE, Smart Bluetooth Hearing Aid (ITE)2023-08-07
16975925880147 - JIUYEE, Smart Bluetooth Hearing Aid (ITE)2023-08-07
16975925880154 - JIUYEE, Smart Bluetooth Hearing Aid (ITE)2023-08-07
06975925880096 - JIUYEE, Smart Bluetooth Hearing Aid (RIC)2023-04-25 The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell
06975925880102 - JIUYEE, Smart Bluetooth Hearing Aid (RIC)2023-04-25 The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell
06975925880119 - JIUYEE, Smart Bluetooth Hearing Aid (RIC)2023-04-25 The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell
06975925880126 - JIUYEE, Smart Bluetooth Hearing Aid (RIC)2023-04-25 The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell

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