Duns Number:832875905
Device Description: PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct)Individually Wrapped Foil Packs for PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct)Individually Wrapped Foil Packs for Professional Use
Catalog Number
051700
Brand Name
PRODIGY PRO No Coding Blood Glucose Test Strips
Version/Model Number
051700
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
K152599,K152599,K152599,K152599
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
775aadac-ceff-4111-bb88-67b793ef1864
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
Package DI Number
30384840517005
Quantity per Package
15
Contains DI Package
00384840517004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner 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 |