Beat

GUDID 00863398000225

Upper arm blood pressure monitor.

LEXINGTON WELLNESS HOLDINGS INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00863398000225
• NIH Device Record Key: 0d0c4191-7eff-4e36-9c5f-4e82cbd3948c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beat
• Version Model Number: F1701T
• Company DUNS: 079437338
• Company Name: LEXINGTON WELLNESS HOLDINGS 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: false
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863398000225 [Primary]
GS1	10863398000222 [Package]; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220886

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: 2023-07-04
• Device Publish Date: 2023-06-26

On-Brand Devices [Beat]

• 10863398000284: Upper arm blood pressure monitor.
• 00863398000225: Upper arm blood pressure monitor.