OneTouch Verio Flex 023-932

GUDID 20353885011765

OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement

LifeScan Europe GmbH

Glucose analyser IVD, home-use

• Primary Device ID: 20353885011765
• NIH Device Record Key: ccd7266d-9ee1-4644-a848-048b9c354939
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio Flex
• Version Model Number: 023-932
• Catalog Number: 023-932
• 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: +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 Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885011761 [Primary]
GS1	20353885011765 [Package]; Contains: 00353885011761; Package: Shipper case [10 Units]; In Commercial Distribution
NDC/NHRIC	53885-932-02 [Secondary]

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: 2
• Public Version Date: 2019-07-26
• Device Publish Date: 2018-06-27

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