Aile

GUDID 06971209161028

Shenzhen Yuezhongxing Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06971209161028
• NIH Device Record Key: b26840e8-80d9-445c-9a1a-9d6eaad6e01f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aile
• Version Model Number: 111
• Company DUNS: 418012517
• Company Name: Shenzhen Yuezhongxing Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971209161028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222926

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2023-07-27
• Device Publish Date: 2023-07-19

Devices Manufactured by Shenzhen Yuezhongxing Technology Co., Ltd.

• 06971209161059 - Safety Wercs: 2023-12-01
• 06971209162025 - Safety Wercs: 2023-12-01
• 06971209160106 - Aleshon: 2023-07-27
• 06971209160113 - Aleshon: 2023-07-27
• 06971209160120 - Aleshon: 2023-07-27
• 06971209160137 - Aleshon: 2023-07-27
• 06971209160144 - Aleshon: 2023-07-27
• 06971209160151 - Aleshon: 2023-07-27