LINNER

GUDID 16932825300083

Hearing Aids (B240)

Guangdong Transtek Medical Electronics Co.,Ltd

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 16932825300083
• NIH Device Record Key: 479a410e-0c8b-40ff-9502-877623519ff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINNER
• Version Model Number: Nova
• Company DUNS: 679794078
• Company Name: Guangdong Transtek Medical Electronics 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932825301410 [Primary]
GS1	16932825300083 [Package]; Contains: 06932825301410; Package: [40 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: 2023-05-15
• Device Publish Date: 2023-05-06

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• 06932825302042 - DrKumo: 2023-11-28 DrKumo Gen 2 Cellular Blood Pressure Monitor
• 06932825302035 - Patient Doctor Connect &TeleRPM: 2023-11-23 TeleRPM Blood Pressure Monitor
• 06932825301458 - Lifehood: 2023-09-13 Blood pressure monitor:TMB-2084-KT-003
• 06932825301465 - Lifehood: 2023-09-13 Blood pressure monitor:TMB-2085-008