Duns Number:688840958
Device Description: VeraSens Voice Blood Glucose Test Strip
Catalog Number
-
Brand Name
VeraSens Voice
Version/Model Number
282104-201
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
K121133,K121133,K121133,K121133
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
2a721fe0-f7c4-411a-ba88-ba365e1464ae
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20857513006203
Quantity per Package
10
Contains DI Package
10857513006206
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |