OneTouch Verio Control Solution 01181803

GUDID 20353885011963

LifeScan Europe GmbH

Glucose monitoring system IVD, point-of-care

• Primary Device ID: 20353885011963
• NIH Device Record Key: 89d7cf85-84e0-4f5d-a4de-8647f5642654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio Control Solution
• Version Model Number: 011818
• Catalog Number: 01181803
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 75
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885011969 [Primary]
GS1	20353885011963 [Package]; Contains: 00353885011969; Package: [1000 Units]; In Commercial Distribution
GS1	80353885011965 [Unit of Use]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2020-10-22
• Device Publish Date: 2020-10-14

Devices Manufactured by LifeScan Europe GmbH

• 20353885012793 - OneTouch Verio Flex: 2024-10-02 OneTouch Verio Flex Blood Glucose Monitoring System
• 20353885012953 - OneTouch Verio Reflect: 2024-05-27 OneTouch Verio Reflect Blood Glucose Monitoring System. System Kit.
• 20353885012830 - OneTouch Ultra Plus Flex: 2024-02-08 OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012106 - OneTouch Ultra Plus Flex: 2022-09-08 OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012618 - OneTouch Verio: 2022-09-08 OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For in vitro diagnostic use. For sel
• 20353885012625 - OneTouch Ultra Plus Flex: 2022-09-08 OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012632 - OneTouch Ultra Plus: 2022-09-08 OneTouch Ultra® Plus strips work with OneTouch Ultra Plus Flex(TM) meter.
• 80353885012641 - OneTouch Ultra Plus: 2022-09-08 OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.