Duns Number:043081723
Device Description: Advocate Redi-Code+ Test Strips for accurate monitoring of blood glucose levels 35 Count
Catalog Number
BMB002-35
Brand Name
Advocate Redi-Code+ Test Strips for Blood Glucose 35 Count
Version/Model Number
BMB002-35
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
-
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
3961b638-8a66-48f3-818a-97ed7553a3da
Public Version Date
November 25, 2020
Public Version Number
5
DI Record Publish Date
August 19, 2016
Package DI Number
20894046001879
Quantity per Package
400
Contains DI Package
00894046001875
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BMB002-35-C
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |