Duns Number:043081723
Device Description: Advocate Redi-Code+ Non Speaking Blood Glucose Meter
Catalog Number
BMB-001A
Brand Name
Advocate Redi-Code+ Non Speaking Blood Glucose Meter
Version/Model Number
BMB-001A
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
ea41d41d-45c1-418c-a9d3-b355fc0c78c7
Public Version Date
November 09, 2020
Public Version Number
4
DI Record Publish Date
August 18, 2016
Package DI Number
10894046001568
Quantity per Package
50
Contains DI Package
00894046001561
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BMB-001A-C
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |