FOND Arm Blood Pressure Monitor

GUDID 06953775650083

Alicn Medical Shenzhen, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953775650083
• NIH Device Record Key: 5908b054-f4ce-4cc5-910d-6f5a290f4d3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOND Arm Blood Pressure Monitor
• Version Model Number: AES-U131
• 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	06953775650083 [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: 2019-04-20

On-Brand Devices [FOND Arm Blood Pressure Monitor]

• 06953775650205: AES-U612
• 06953775650199: AES-U611
• 06953775650182: AES-U631
• 06953775650175: AES-U632
• 06953775650168: AES-U512
• 06953775650151: AES-U321
• 06953775650144: AES-U311
• 06953775650137: AES-U522
• 06953775650120: AES-U361
• 06953775650113: AES-U351
• 06953775650106: AES-U151
• 06953775650090: AES-U141
• 06953775650083: AES-U131
• 06953775650069: AES-U181
• 06953775650052: AES-U171
• 06953775620147: AES-U341
• 06953775620130: AES-U331
• 06953775620123: AES-U121
• 06953775620116: AES-U161