Duns Number:832875905
Device Description: PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patient PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
Catalog Number
051775
Brand Name
PRODIGY Astro PRO Blood Glucose Monitoring System
Version/Model Number
051775
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
d9ebe93a-0a53-4be9-ab4d-068a2bbedd8e
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
Package DI Number
30384840517753
Quantity per Package
10
Contains DI Package
00384840517752
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| 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 |