Dario 200 Test Strips Bundle

GUDID 00850065006574

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.

LABSTYLE INNOVATION LTD

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• Primary Device ID: 00850065006574
• NIH Device Record Key: 2bfa8f9f-534a-4d09-bbbb-8c638b6f13fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario 200 Test Strips Bundle
• Version Model Number: 1213-05
• 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: 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	00850065006574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150817

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2020-09-03
• Device Publish Date: 2020-08-26

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• 00850065006574 - Dario 200 Test Strips Bundle: 2020-09-03 The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in