OneTouch Verio Flex

GUDID 20353885012489

OneTouch Verio Flex Blood Glucose Monitoring System

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885012489
• NIH Device Record Key: 153e95c9-6bd4-4a3a-961c-7ae178ad1470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio Flex
• Version Model Number: 024-267
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 8885673003
• Email: XX@XX.XX
• Phone: 8885673003
• Email: XX@XX.XX
• Phone: 8885673003
• Email: XX@XX.XX
• Phone: 8885673003
• Email: XX@XX.XX
• Phone: 8885673003
• Email: XX@XX.XX
• Phone: 8885673003
• Email: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885012485 [Primary]
GS1	20353885012489 [Package]; Contains: 00353885012485; Package: Shipper case [10 Units]; In Commercial Distribution

FDA Product Code

• LFR: Glucose Dehydrogenase, 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: 2022-05-27
• Device Publish Date: 2022-05-19

On-Brand Devices [OneTouch Verio Flex]

• 20353885011765: OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for
• 20353885010980: OneTouch Verio Flex Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testi
• 20353885010973: OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for
• 20353885010713: OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip.
• 20353885011840: OneTouch Verio Flex Blood Glucose Monitoring System.
• 20353885011833: OneTouch Verio Flex Blood Glucose Monitoring System.
• 20353885012489: OneTouch Verio Flex Blood Glucose Monitoring System