Duns Number:028662035
Device Description: Blood Glucose Test Strips
Catalog Number
-
Brand Name
Pro Voice
Version/Model Number
V8/V9
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072039,K090188,K072039,K090188
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
93ad6d1b-7985-4f24-ab90-a2159fc767de
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |