Duns Number:480240820
Device Description: OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-test OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
Catalog Number
022-657
Brand Name
OneTouch Verio
Version/Model Number
022-657
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
K131363,K131363
Product Code
LFR
Product Code Name
Glucose dehydrogenase, glucose
Public Device Record Key
43e67605-5523-4b5d-806a-d3eb3eb8b88e
Public Version Date
July 26, 2019
Public Version Number
4
DI Record Publish Date
September 13, 2017
Package DI Number
20353885008710
Quantity per Package
4
Contains DI Package
00353885008716
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 |