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 |
| 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 |
| 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 |
On-Brand Devices [OneTouch Verio Flex]
| 20353885011765 | OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for |
| 20353885010980 | OneTouch Verio Flex Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testi |
| 20353885010973 | OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for |
| 20353885010713 | OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. |
| 20353885011840 | OneTouch Verio Flex Blood Glucose Monitoring System. |
| 20353885011833 | OneTouch Verio Flex Blood Glucose Monitoring System. |
| 20353885012489 | OneTouch Verio Flex Blood Glucose Monitoring System |
| 20353885012793 | OneTouch Verio Flex Blood Glucose Monitoring System |
Trademark Results [OneTouch Verio Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONETOUCH VERIO FLEX 86468482 4999116 Live/Registered |
Johnson & Johnson 2014-12-02 |
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