OneTouch Ultra2 021-098

GUDID 20353885000271

OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip

LifeScan Europe GmbH

Blood lancing device tip

• Primary Device ID: 20353885000271
• NIH Device Record Key: ef4572f2-500b-49d7-b01a-782bf5a9eacd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra2
• Version Model Number: 021-098
• Catalog Number: 021-098
• 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(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

• Device Size Text, specify: 0
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 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 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885000277 [Primary]
GS1	20353885000271 [Package]; Contains: 00353885000277; Package: Shipper case [4 Units]; In Commercial Distribution
NDC/NHRIC	53885-448-01 [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.