Duns Number:480240820
Device Description: OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing.
Catalog Number
-
Brand Name
OneTouch Verio
Version/Model Number
013-046
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
Yes
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,K120708,K110637,K110637,K120708,K131363,K120708,K131363,K110637
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
3c72bfaa-559d-4f3e-b37c-0d1864d4a39a
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 18, 2021
Package DI Number
20353885012427
Quantity per Package
450
Contains DI Package
00353885012423
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 |