DaliaSense

GUDID 00860011532828

A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood pressure, and an AI analysis for irregular heartbeats.

Stethoai LLC

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• Primary Device ID: 00860011532828
• NIH Device Record Key: 54f70f44-3bba-49d8-b098-842db8c5e10c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DaliaSense
• Version Model Number: 1
• Company DUNS: 119180228
• Company Name: Stethoai LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011532828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193348

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: 2024-04-23
• Device Publish Date: 2024-04-15

Devices Manufactured by Stethoai LLC

• 00860011532828 - DaliaSense: 2024-04-23A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood pressure, and an AI analysis for irregular heartbeats.
• 00860011532828 - DaliaSense: 2024-04-23 A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood
• 00860011532804 - StethoAI Digital Stethoscope: 2024-01-26 A high-quality digital stethoscope that connects directly to the 3.5mm jack of your computer or your mobile phone.