Dario Blood Glucose Monitoring System

GUDID 00850065006161

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

Glucose monitoring system IVD, home-use

• Primary Device ID: 00850065006161
• NIH Device Record Key: 85648e34-a1e9-4c98-8d98-e8f78aa93d0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario Blood Glucose Monitoring System
• Version Model Number: 1015-05
• 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: false
• Device Combination Product: false
• Single Use: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850065006161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150817

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2019-03-11
• Device Publish Date: 2019-02-07

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