Duns Number:169895245
Device Description: Kroger Blood Glucose Meter Kit
Catalog Number
909001
Brand Name
Kroger Healthpro
Version/Model Number
909001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
d040b56f-cf9c-4f79-a30d-e6018a7e5a43
Public Version Date
December 09, 2019
Public Version Number
1
DI Record Publish Date
December 01, 2019
Package DI Number
MHC19090013
Quantity per Package
6
Contains DI Package
MHC19090012
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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. | 184 |