Duns Number:832875905
Device Description: Prodigy AutoCode Blood Glucose Monitoring System
Catalog Number
074300
Brand Name
Prodigy AutoCode Blood Glucose Monitoring System
Version/Model Number
074300
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
K073118,K073118,K073118
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
9eebaccf-f35a-4242-afee-bbf178941c47
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 07, 2016
Package DI Number
00384843743004
Quantity per Package
10
Contains DI Package
00384840743007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Box
| 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 |