Dario Blood Glucose Monitoring System

GUDID 00850065006000

The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.

LABSTYLE INNOVATION LTD

Home-use/point-of-care blood glucose/blood pressure monitoring system

• Primary Device ID: 00850065006000
• NIH Device Record Key: 93ff127e-4611-4321-8b8c-9b6f0d14ff1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario Blood Glucose Monitoring System
• Version Model Number: 1015-01
• Company DUNS: 600039072
• Company Name: LABSTYLE INNOVATION LTD
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00850065006000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150817

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-12

On-Brand Devices [Dario Blood Glucose Monitoring System]

• 00850065006161: The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitr
• 00850065006000: The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitr