OneTouch Ultra Plus
GUDID 80353885012641
OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.
LifeScan Europe GmbH
Glucose IVD, control| Primary Device ID | 80353885012641 |
| NIH Device Record Key | 5d1c6fc2-3097-4150-a867-54302fcf4f0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneTouch Ultra Plus |
| Version Model Number | 024-272 |
| Company DUNS | 480240820 |
| Company Name | LifeScan Europe GmbH |
| Device Count | 75 |
| 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 | false |
| 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 | |
| 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
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Degrees Fahrenheit and 65 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00353885012645 [Primary] |
| GS1 | 20353885012649 [Package] Contains: 00353885012645 Package: Shipper case [48 Units] In Commercial Distribution |
| GS1 | 80353885012641 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-08 |
| Device Publish Date | 2022-08-31 |
On-Brand Devices [OneTouch Ultra Plus]
| 20353885012687 | OneTouch Ultra Plus™ Level 4 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter. |
| 80353885012641 | OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter. |
| 20353885012632 | OneTouch Ultra® Plus strips work with OneTouch Ultra Plus Flex(TM) meter. |
Trademark Results [OneTouch Ultra Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONETOUCH ULTRA PLUS 97350212 not registered Live/Pending |
LifeScan IP Holdings, LLC 2022-04-06 |
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