OneTouch Ultra Plus
GUDID 20353885012687
OneTouch Ultra Plus™ Level 4 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.
LifeScan Europe GmbH
Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control| Primary Device ID | 20353885012687 |
| NIH Device Record Key | 34a5d509-7cb5-4fe3-a293-c6a7b034cdd4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneTouch Ultra Plus |
| Version Model Number | 024-282 |
| 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 | 00353885012683 [Primary] |
| GS1 | 20353885012687 [Package] Contains: 00353885012683 Package: Shipper case [48 Units] In Commercial Distribution |
| GS1 | 80353885012689 [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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