OneTouch Ultra2 023-065

GUDID 20353885010515

OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.

LifeScan Europe GmbH

Glucose analyser IVD, home-use

• Primary Device ID: 20353885010515
• NIH Device Record Key: 52f967a9-e676-4d58-9342-b7bdc66032dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra2
• Version Model Number: 023-065
• Catalog Number: 023-065
• 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: false
• 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(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX
• Phone: +1(800)227-8862
• Email: XX@XX.XX

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• 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 *Do not refrigerate
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885010511 [Primary]
GS1	20353885010515 [Package]; Contains: 00353885010511; Package: Shipper case [10 Units]; In Commercial Distribution
NDC/NHRIC	53885-065-01 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053529

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: 4
• Public Version Date: 2019-07-26
• Device Publish Date: 2017-09-13

On-Brand Devices [OneTouch Ultra2]

• 20353885010515: OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.
• 20353885010010: OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. Not f
• 20353885008857: OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or re
• 20353885008376: OneTouch Ultra2 Blood Glucose Monitoring Meter - Warranty replacement
• 20353885000271: OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra
• 20353885011857: OneTouch Ultra2 Blood Glucose Monitoring System.