ERDPAA Arm Blood Pressure Monitor

GUDID 06953775660105

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953775660105
• NIH Device Record Key: 34ca9c49-5557-41e5-98a9-07caf40dacad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERDPAA Arm Blood Pressure Monitor
• Version Model Number: AES-U112-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: true
• Expiration Date: true
• Donation Id Number: true
• 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	06953775660105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230649

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: 2024-04-19
• Device Publish Date: 2024-04-11

On-Brand Devices [ERDPAA Arm Blood Pressure Monitor]

• 06953775660105: AES-U112-A
• 06953775660297: AES-U231-A