OneTouch Verio Reflect
GUDID 20353885011710
OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit
LifeScan Europe GmbH
Glucose monitoring system IVD, home-use| Primary Device ID | 20353885011710 |
| NIH Device Record Key | 6618314e-1b23-4e25-9b0b-eca86419f323 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneTouch Verio Reflect |
| Version Model Number | 023-899 |
| 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 |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit 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 *Sore unused test strips in the original vial |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and heat |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00353885011716 [Primary] |
| GS1 | 20353885011710 [Package] Contains: 00353885011716 Package: shipper container [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193475
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 | 2020-03-09 |
| Device Publish Date | 2020-02-28 |
On-Brand Devices [OneTouch Verio Reflect]
| 20353885011727 | OneTouch Verio Reflect Blood Glucose Monitoring System. Warranty Kit |
| 20353885011710 | OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit |
| 20353885011703 | 023-878 |
| 20353885011697 | 023-927 |
| 20353885012434 | OneTouch Verio Reflect Blood Glucose Monitoring System. Value Pack Kit |
| 20353885012472 | OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit. |
| 20353885012953 | OneTouch Verio Reflect Blood Glucose Monitoring System. System Kit. |
Trademark Results [OneTouch Verio Reflect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONETOUCH VERIO REFLECT 87713865 not registered Live/Pending |
LifeScan IP Holdings, LLC 2017-12-08 |
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