ERDPAA Arm Blood Pressure Monitor

GUDID 06953775660297

Alicn Medical Shenzhen, Inc.

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• Primary Device ID: 06953775660297
• NIH Device Record Key: 4475370a-90c2-41eb-981e-654f69ed5d8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERDPAA Arm Blood Pressure Monitor
• Version Model Number: AES-U231-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	06953775660297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231050

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: 2024-07-15
• Device Publish Date: 2024-07-05

On-Brand Devices [ERDPAA Arm Blood Pressure Monitor]

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