JIUYEE, Smart Bluetooth Hearing Aid (ITE)

GUDID 16975925880154

Hunan JIUYEE Medical Technology Co., Ltd

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 16975925880154
• NIH Device Record Key: 0028d4c6-7b8b-4c46-be44-81c7ac3f316d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JIUYEE, Smart Bluetooth Hearing Aid (ITE)
• Version Model Number: Air C2, Pearl White
• Company DUNS: 699350218
• Company Name: Hunan JIUYEE Medical Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975925880157 [Primary]
GS1	16975925880154 [Package]; Contains: 06975925880157; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• QUG: Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-07
• Device Publish Date: 2023-07-30

On-Brand Devices [JIUYEE, Smart Bluetooth Hearing Aid (ITE)]

• 16975925880154: Air C2, Pearl White
• 16975925880147: Air C2, Jade Gold
• 16975925880130: Air C2, Emerald Black