Dario Blood Pressure Monitoring System (M cuff)

GUDID 00850033352085

The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over. The Dario Blood Pressure Monitoring System provides Bluetooth transmission.

DARIOHEALTH CORP.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00850033352085
• NIH Device Record Key: 2dffe1d1-4a5f-44d0-ad1f-2bdbba9ad2d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario Blood Pressure Monitoring System (M cuff)
• Version Model Number: 1160-05
• 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	00850033352085 [Primary]

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: 2021-11-15
• Device Publish Date: 2021-11-07

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