Zepp Clarity Omni

GUDID 00850058994000

Anhui Huami Information Technology Co., Ltd.

Air-conduction hearing aid, canal

• Primary Device ID: 00850058994000
• NIH Device Record Key: 77de5352-6db7-4c82-9654-ef224ef4b6d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zepp Clarity Omni
• Version Model Number: A2317
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850058994000 [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: 2023-12-06
• Device Publish Date: 2023-11-28

On-Brand Devices [Zepp Clarity Omni]

• 00850051482832: A2317
• 00850058994000: A2317