OneTouch Ultramini 021-208

GUDID 20353885000486

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip

LifeScan Europe GmbH

Glucose analyser IVD, home-use

• Primary Device ID: 20353885000486
• NIH Device Record Key: 3cf89a12-b39c-4cb9-b305-01b42ef36787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultramini
• Version Model Number: 021-208
• Catalog Number: 021-208
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885000482 [Primary]
GS1	20353885000486 [Package]; Contains: 00353885000482; Package: Shipper case [4 Units]; In Commercial Distribution
NDC/NHRIC	53885-208-01 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061118

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 Ultramini]

• 20353885011468: OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
• 20353885008161: OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
• 20353885008130: OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
• 20353885002688: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
• 20353885002671: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ult
• 20353885001315: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
• 20353885001285: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ult
• 20353885000516: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
• 20353885000486: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or