ETEKCITY Arm Blood Pressure Monitor

GUDID 06953775650335

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953775650335
• NIH Device Record Key: b3f283ec-3232-475e-bf86-2b3302b00468
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETEKCITY Arm Blood Pressure Monitor
• Version Model Number: AES-U522-A
• 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: 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	06953775650335 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-08

On-Brand Devices [ETEKCITY Arm Blood Pressure Monitor]

• 06953775650342: AES-U631-A
• 06953775650335: AES-U522-A