BBLOVE Arm Blood Pressure Monitor

GUDID 06953775658515

Alicn Medical Shenzhen, Inc.

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• Primary Device ID: 06953775658515
• NIH Device Record Key: c7dd104b-43b3-45df-9e3d-3ec86558edce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BBLOVE Arm Blood Pressure Monitor
• Version Model Number: AES-U121-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: 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	06953775658515 [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: 2020-09-16
• Device Publish Date: 2020-09-08

On-Brand Devices [BBLOVE Arm Blood Pressure Monitor]

• 06953775600071: AES-U181-I
• 06953775600217: AES-U171-D
• 06953775658515: AES-U121-A
• 06953775658836: AES-U311-A
• 06953775658829: AES-U231
• 06953775601030: AES-U131-D
• 06953775601320: AES-U331-C
• 06953775659406: AES-U522-B