Duns Number:006999528
Device Description: Test Strips, Kroger, Premium, 50CT, 100CT
Catalog Number
-
Brand Name
Kroger Premium Blood Glucose Test Strips
Version/Model Number
8000-06762
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
-
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
8558dad8-ea04-4ec0-8543-0d9557bbbf03
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20041260360705
Quantity per Package
12
Contains DI Package
00041260360701
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |