OneTouch Verio Flex 02404501

GUDID 20353885011840

OneTouch Verio Flex Blood Glucose Monitoring System.

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885011840
• NIH Device Record Key: 7be8f57b-7845-40f1-ab17-a59f7462a983
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio Flex
• Version Model Number: 024045
• Catalog Number: 02404501
• 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

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 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Store your test strips in the vial only
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885011846 [Primary]
GS1	20353885011840 [Package]; Contains: 00353885011846; Package: shipper case [10 Units]; In Commercial Distribution
NDC/NHRIC	53885-045-01 [Secondary]

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: 2019-03-21
• Device Publish Date: 2019-03-13

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• 20353885010713: OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip.
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• 20353885011833: OneTouch Verio Flex Blood Glucose Monitoring System.
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• 20353885012793: OneTouch Verio Flex Blood Glucose Monitoring System