Dario Super Saver MIB-Supplies

GUDID 00850065006659

LABSTYLE INNOVATION LTD

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• Primary Device ID: 00850065006659
• NIH Device Record Key: f6851fd2-ffec-4472-9160-39c8d9501d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dario Super Saver MIB-Supplies
• Version Model Number: 1216-05
• Company DUNS: 600039072
• Company Name: LABSTYLE INNOVATION LTD
• Device Count: 1
• DM Exempt: false
• 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: true
• 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	00850065006659 [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: 2021-07-23
• Device Publish Date: 2021-07-15

Devices Manufactured by LABSTYLE INNOVATION LTD

• 00850065006741 - Dario® USB-C Blood Glucose Monitoring System- Welcome Kit: 2023-12-29 The Dario USB-C Blood Glucose Monitoring System Welcome Kit is a compact, all-in-one blood glucose meter that is used in conjunc
• 00850065006758 - Dario® USB-C Blood Glucose Monitoring System - Starter Kit: 2023-12-29 The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a
• 00850033352023 - Dario Smart Scale (Cellular) - Weight Management System: 2021-10-25 The Dario Smart Scale (Cellular) - Weight Management System is intended for measuring the body weight of adults and children (ag
• 00850065006222 - Dario 100 Sterile Lancets: 2021-08-18 The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancin
• 00850033352009 - Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System: 2021-08-17 The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pr
• 00850065006659 - Dario Super Saver MIB-Supplies: 2021-07-23
• 00850065006659 - Dario Super Saver MIB-Supplies: 2021-07-23
• 00850065006567 - Dario 300 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
• 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