OneTouch Verio Reflect

GUDID 20353885011703

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885011703
• NIH Device Record Key: 930ea4b9-b9f7-4c5f-9571-dabe2b355a21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio Reflect
• Version Model Number: 023-878
• 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: 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store unused strips in the original vial
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885011709 [Primary]
GS1	20353885011703 [Package]; Contains: 00353885011709; Package: shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193475

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [OneTouch Verio Reflect]

• 20353885011727: OneTouch Verio Reflect Blood Glucose Monitoring System. Warranty Kit
• 20353885011710: OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit
• 20353885011703: 023-878
• 20353885011697: 023-927
• 20353885012434: OneTouch Verio Reflect Blood Glucose Monitoring System. Value Pack Kit
• 20353885012472: OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit.
• 20353885012953: OneTouch Verio Reflect Blood Glucose Monitoring System. System Kit.