OneTouch Verio 023-061

GUDID 20353885010485

OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters. For Kaiser Permanente Members Only

LifeScan Europe GmbH

Glucose IVD, kit, electrometry

• Primary Device ID: 20353885010485
• NIH Device Record Key: 268cc46c-22e0-4cca-b76a-fe1ac961e0fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio
• Version Model Number: 023-061
• Catalog Number: 023-061
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 100
• 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: 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

Customer Support Contacts

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Discard 6 months after opening
• Special Storage Condition, Specify: Between 0 and 0 *Discard 6 months after opening
• Special Storage Condition, Specify: Between 0 and 0 *Discard 6 months after opening

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885010481 [Primary]
GS1	20353885010485 [Package]; Contains: 00353885010481; Package: Shipper case [120 Units]; In Commercial Distribution
NDC/NHRIC	53885-061-50 [Secondary]
GS1	80353885010487 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110637

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: 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