OneTouch Verio
GUDID 20353885012786
OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing
LifeScan Europe GmbH
Glucose IVD, kit, electrometry| Primary Device ID | 20353885012786 |
| NIH Device Record Key | 6d9f3c6c-b591-401d-9b33-a8ecd11d18e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneTouch Verio |
| Version Model Number | 024-328 |
| Company DUNS | 480240820 |
| Company Name | LifeScan Europe GmbH |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX | |
| Phone | 1 888 567-3003 |
| XX@XX.XX |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00353885012782 [Primary] |
| GS1 | 20353885012786 [Package] Contains: 00353885012782 Package: Shipper case [24 Units] In Commercial Distribution |
| GS1 | 80353885012788 [Unit of Use] |
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 | 2 |
| Public Version Date | 2025-06-19 |
| Device Publish Date | 2022-12-23 |
On-Brand Devices [OneTouch Verio]
| 20353885011550 | OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. Fo |
| 20353885010485 | OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood gluco |
| 20353885010034 | OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood gluco |
| 20353885009762 | OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou |
| 20353885009755 | OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou |
| 20353885008734 | OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo |
| 20353885008727 | OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo |
| 20353885008710 | OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo |
| 20353885007737 | OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou |
| 20353885007720 | OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou |
| 20353885012038 | OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For |
| 20353885007775 | OneTouch Verio®Level 4 Control Solution |
| 53885-273-02 | OneTouch Verio®Level 3 Control Solution |
| 20353885012182 | OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For |
| 20353885012427 | OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For |
| 20353885012595 | OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For |
| 20353885012618 | OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For |
| 20353885012786 | OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For |
Trademark Results [OneTouch Verio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONETOUCH VERIO 77510844 4112124 Live/Registered |
LIFESCAN IP HOLDINGS, LLC 2008-06-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.