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
024-174
Brand Name
OneTouch Verio
Version/Model Number
024-174
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
K110637,K120708,K131363,K110637,K120708,K131363,K110637,K120708,K131363
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
7321f4dd-602c-4f69-b6c7-b7879b8c839a
Public Version Date
April 20, 2020
Public Version Number
1
DI Record Publish Date
April 12, 2020
Package DI Number
20353885012038
Quantity per Package
450
Contains DI Package
00353885012034
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 |