Beat

GUDID 10863398000284

Upper arm blood pressure monitor.

LEXINGTON WELLNESS HOLDINGS INC.

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• Primary Device ID: 10863398000284
• NIH Device Record Key: c7e22b97-fb93-4a20-9fd3-61e0443349c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beat
• Version Model Number: B02T
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863398000287 [Primary]
GS1	10863398000284 [Package]; Contains: 00863398000287; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172171

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: 2020-10-09
• Device Publish Date: 2020-10-01

On-Brand Devices [Beat]

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