Zepp Clarity Pixie Open Dome S

GUDID 00850051482313

Anhui Huami Information Technology Co., Ltd.

Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal Air-conduction hearing aid, canal

• Primary Device ID: 00850051482313
• NIH Device Record Key: cc9d1f12-02b5-4028-82a5-ad1fe4696351
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zepp Clarity Pixie Open Dome S
• Version Model Number: A2310Y
• Company DUNS: 421368652
• Company Name: Anhui Huami Information 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: true
• Serial Number: false
• 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	00850051482313 [Primary]

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: 2023-08-24
• Device Publish Date: 2023-08-16

Devices Manufactured by Anhui Huami Information Technology Co., Ltd.

• 00850051482931 - Zepp Clarity Tulip Dome: 2023-12-06
• 00850051482948 - Zepp Clarity Open Dome S: 2023-12-06
• 00850051482955 - Zepp Clarity Open Dome M: 2023-12-06
• 00850051482962 - Zepp Clarity Open Dome L: 2023-12-06
• 00850051482979 - Zepp Clarity Closed Dome S: 2023-12-06
• 00850051482986 - Zepp Clarity Closed Dome M: 2023-12-06
• 00850051482993 - Zepp Clarity Closed Dome L: 2023-12-06
• 00850058994000 - Zepp Clarity Omni: 2023-12-06