Dario Blood Pressure Monitoring System (M cuff)

GUDID 00850065006345

DARIOHEALTH CORP.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00850065006345
• NIH Device Record Key: 6bed86c9-8078-4a43-8057-032b6c621dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario Blood Pressure Monitoring System (M cuff)
• Version Model Number: TD-3128
• Company DUNS: 116902485
• Company Name: DARIOHEALTH CORP.
• 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: false
• Serial Number: true
• 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	00850065006345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112216

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: 2020-01-31
• Device Publish Date: 2020-01-23

On-Brand Devices [Dario Blood Pressure Monitoring System (M cuff)]

• 00850065006345: TD-3128
• 00850033352085: The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and di