OneTouch Ultra2 02404601

GUDID 20353885011857

OneTouch Ultra2 Blood Glucose Monitoring System.

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885011857
• NIH Device Record Key: 83d6edaa-3d6b-42c6-b33a-3d33892e9f57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra2
• Version Model Number: 024-046
• Catalog Number: 02404601
• 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: 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: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX

Device Dimensions

• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 30 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885011853 [Primary]
GS1	20353885011857 [Package]; Contains: 00353885011853; Package: shipper case [4 Units]; In Commercial Distribution
NDC/NHRIC	53885-046-01 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-20
• Device Publish Date: 2019-03-12

On-Brand Devices [OneTouch Ultra2]

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• 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.