DEVICE: OneTouch Verio Flex (00353885011761)
Device Identifier (DI) Information
OneTouch Verio Flex
023-932
In Commercial Distribution
023-932
LifeScan Europe GmbH
023-932
In Commercial Distribution
023-932
LifeScan Europe GmbH
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 62645 | Glucose analyser IVD, home-use |
An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.
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Active | false |
| 53303 | Glucose IVD, kit, electrometry |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.
|
Active | false |
| 62537 | Glucose monitoring system IVD, home-use |
A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
| LFR | Glucose dehydrogenase, glucose |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Store your test strips in the vial only |
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify: Keep away from direct sunlight and heat |
| Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify: Operating Altitude up to 10000 Feet |
| Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Blood Glucose measurement Level mg/dL |
| Device Size Text, specify: Hematocrit 20 - 60% |
Device Record Status
ccd7266d-9ee1-4644-a848-048b9c354939
June 19, 2025
3
June 27, 2018
June 19, 2025
3
June 27, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20353885011765 | 10 | 00353885011761 | In Commercial Distribution | Shipper case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| NDC/NHRIC | 53885-932-02 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)567-3003
XX@XX.XX
XX@XX.XX