Dario Glucose Control Solution

GUDID 00850065006215

Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing.

LABSTYLE INNOVATION LTD

Glucose IVD, control

• Primary Device ID: 00850065006215
• NIH Device Record Key: 86447f38-c7af-4da6-ae6b-153d35500e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario Glucose Control Solution
• Version Model Number: 1054-05
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00850065006215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150817

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-25

On-Brand Devices [Dario Glucose Control Solution]

• 00850065006215: Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System man
• 00850065006048: Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System man