Duns Number:480240820
Device Description: OneTouch Verio®Level 3 Control Solution
Catalog Number
022-273
Brand Name
OneTouch Verio
Version/Model Number
022-273
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
bb1a5a80-3bc6-449d-a25e-7ae9cf5570f5
Public Version Date
December 03, 2019
Public Version Number
1
DI Record Publish Date
November 25, 2019
Package DI Number
20353885007768
Quantity per Package
48
Contains DI Package
00353885007764
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 |