Sinocare Arm Blood Pressure Monitor

GUDID 06953775658997

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953775658997
• NIH Device Record Key: 5ad3ff20-3705-4557-9d87-0c348443447d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sinocare Arm Blood Pressure Monitor
• Version Model Number: AES-U311-B
• Company DUNS: 548040741
• Company Name: Alicn Medical Shenzhen, Inc.
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953775658997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180435

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: 2021-06-11
• Device Publish Date: 2021-06-03

On-Brand Devices [Sinocare Arm Blood Pressure Monitor]

• 06953775658256: AES-U131-A
• 06953775658232: black
• 06953775658225: white
• 06953775658997: AES-U311-B
• 06953775658980: AES-U111-B
• 06953775658973: AES-U111-A