BBLOVE Arm Blood Pressure Monitor

GUDID 06953775609203

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953775609203
• NIH Device Record Key: b5a16629-ab5b-4588-90f4-cc7a80212f26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BBLOVE Arm Blood Pressure Monitor
• Version Model Number: AES-U612-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: 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	06953775609203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221913

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: 2024-09-30
• Device Publish Date: 2024-09-20

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
• 06953775660112: AES-U214
• 06953775633345: AES-U392-A
• 06953775609227: AES-U382-A
• 06953775609210: AES-U112-B
• 06953775609203: AES-U612-B