OneTouch Ultra Plus Flex

GUDID 20353885012106

OneTouch Ultra Plus 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 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 Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885012106
• NIH Device Record Key: 05bebf71-3f47-4c99-8195-75d684b336c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra Plus Flex
• Version Model Number: 024-180
• 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
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx
• Phone: 1 888 567-3003
• Email: xx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885012102 [Primary]
GS1	20353885012106 [Package]; Contains: 00353885012102; Package: Shipper [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: 2022-09-08
• Device Publish Date: 2022-08-31

On-Brand Devices [OneTouch Ultra Plus Flex]

• 20353885012625: OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012106: OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012830: OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System