Duns Number:480240820
Device Description: OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters.For DME Beneficiaries Only
Catalog Number
022-978
Brand Name
OneTouch Verio
Version/Model Number
022-978
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
fac5fd32-40be-4166-a229-0937ee22041a
Public Version Date
July 26, 2019
Public Version Number
4
DI Record Publish Date
September 13, 2017
Package DI Number
20353885010034
Quantity per Package
240
Contains DI Package
00353885010030
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 |