VeriSmart® Health

GUDID 00860013745004

VeriSmart® Health Wireless Upper Arm Smart Blood Pressure Monitor VSH-B550

VERISMART INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00860013745004
• NIH Device Record Key: e9881b77-5967-44b3-a51f-7d7e91d913a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VeriSmart® Health
• Version Model Number: VSH-B550
• Company DUNS: 137201440
• Company Name: VERISMART 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: true
• Lot Batch: true
• 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	00860013745004 [Primary]
GS1	00860013745011 [Package]; Package: Carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222887

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: 2025-12-19
• Device Publish Date: 2025-12-11