Dario® Type-C Blood Glucose Monitoring System - Starter Kit

GUDID 00850065006406

The Dario Type-CBlood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario Type-C meter is connected to a SMD through a USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario Type-C glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006390) The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178)

LABSTYLE INNOVATION LTD

Glucose IVD, kit, enzyme spectrophotometry, rapid

• Primary Device ID: 00850065006406
• NIH Device Record Key: 45d9e5e7-1ebf-4669-8d4b-877096142bb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario® Type-C Blood Glucose Monitoring System - Starter Kit
• Version Model Number: 1200-05
• 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: true
• 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	00850065006406 [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: 2019-11-05
• Device Publish Date: 2019-10-28

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