Dario Smart Blood Pressure Monitor Gen 2

GUDID 00850033352061

The Dario blood pressure monitoring system is intended for measuring blood pressure and heart rate in adults with an arm circumference ranging from 8.75-16.5 inch (22-42 cm). It is intended for adult indoor use only.

DARIOHEALTH CORP.

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• Primary Device ID: 00850033352061
• NIH Device Record Key: d5b3b03f-8e60-4558-90b9-f4351b0fe83b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario Smart Blood Pressure Monitor Gen 2
• Version Model Number: 1217-05
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033352061 [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: 2022-07-05
• Device Publish Date: 2022-06-27

Devices Manufactured by DARIOHEALTH CORP.

• 00850033352061 - Dario Smart Blood Pressure Monitor Gen 2: 2022-07-05The Dario blood pressure monitoring system is intended for measuring blood pressure and heart rate in adults with an arm circumference ranging from 8.75-16.5 inch (22-42 cm). It is intended for adult indoor use only.
• 00850033352061 - Dario Smart Blood Pressure Monitor Gen 2: 2022-07-05 The Dario blood pressure monitoring system is intended for measuring blood pressure and heart rate in adults with an arm circumf
• 00850033352092 - Dario Smart Scale: 2022-07-04 The Dario Smart Scale will accurately measure the weight of children and adults over 20 lbs. (9 kg). The maximum weight limit fo
• 00850033352078 - Dario Blood Pressure Monitoring System (Large cuff): 2021-11-15 The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse
• 00850033352085 - Dario Blood Pressure Monitoring System (M cuff): 2021-11-15 The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse
• 00850065006345 - Dario Blood Pressure Monitoring System (M cuff): 2020-01-31
• 00850065006437 - Dario Blood Pressure Monitoring System (Large cuff): 2020-01-31