Duns Number:480240820
Device Description: OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. N OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
Catalog Number
023-932
Brand Name
OneTouch Verio Flex
Version/Model Number
023-932
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LFR
Product Code Name
Glucose dehydrogenase, glucose
Public Device Record Key
ccd7266d-9ee1-4644-a848-048b9c354939
Public Version Date
July 26, 2019
Public Version Number
2
DI Record Publish Date
June 27, 2018
Package DI Number
20353885011765
Quantity per Package
10
Contains DI Package
00353885011761
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |