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
024-265
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
-
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
248a97f4-188d-4d03-9be9-2c5182f748b5
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
Package DI Number
20353885012595
Quantity per Package
450
Contains DI Package
00353885012591
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |