Hionec

GUDID 06945936703356

Xiamen New Sound Technology Co., Ltd.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 06945936703356
• NIH Device Record Key: c31448ca-a886-47b0-8fa0-c351eb43bda7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hionec
• Version Model Number: Hionec Fit
• Company DUNS: 528181200
• Company Name: Xiamen New Sound Technology Co., Ltd.
• Device Count: 2
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945936703356 [Unit of Use]
GS1	16945936703353 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

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: 2022-09-16
• Device Publish Date: 2022-09-08

Devices Manufactured by Xiamen New Sound Technology Co., Ltd.

• 16945936704831 - PowerLix: 2024-12-19
• 06945936704742 - Newsound: 2024-12-06
• 06945936704759 - Newsound: 2024-12-06
• 06945936704766 - Newsound: 2024-12-06
• 06945936704773 - Newsound: 2024-12-06
• 06945936704780 - Newsound: 2024-12-06
• 06945936704797 - Newsound: 2024-12-06
• 16945936704060 - Nano: 2024-05-29