Duns Number:832875905
Device Description: Prodigy AutoCode Blood Glucose Monitoring System
Catalog Number
070120
Brand Name
Prodigy AutoCode Blood Glucose Monitoring System
Version/Model Number
070120
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
Yes
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
1bf5f0d9-789b-4e6c-99c3-1aed96c1be82
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
00384843701202
Quantity per Package
10
Contains DI Package
00384840701205
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |