OneTouch Verio

GUDID 20353885008734

OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.

LifeScan Europe GmbH

Glucose analyser IVD, home-use

• Primary Device ID: 20353885008734
• NIH Device Record Key: 08e8e6f1-43b6-4fba-a3d1-265cd3287333
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio
• Version Model Number: 022-659
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• 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: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(888)567-3003
• Email: XX@XX.XX

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885008730 [Primary]
GS1	20353885008734 [Package]; Contains: 00353885008730; Package: Shipper case [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131363

FDA Product Code

• LFR: Glucose dehydrogenase, glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-26
• Device Publish Date: 2017-09-13

On-Brand Devices [OneTouch Verio]

• 20353885011550: OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. Fo
• 20353885010485: OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood gluco
• 20353885010034: OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood gluco
• 20353885009762: OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou
• 20353885009755: OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou
• 20353885008734: OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo
• 20353885008727: OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo
• 20353885008710: OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo
• 20353885007737: OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou
• 20353885007720: OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou
• 20353885012038: OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For
• 20353885007775: OneTouch Verio®Level 4 Control Solution
• 53885-273-02: OneTouch Verio®Level 3 Control Solution
• 20353885012182: OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For
• 20353885012427: OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For
• 20353885012595: OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For
• 20353885012618: OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For