Duns Number:031108704
Catalog Number
-
Brand Name
NaviPro™
Version/Model Number
M00556240
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OYC
Product Code Name
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Public Device Record Key
0c4afc77-0530-41c8-9189-b2506102c505
Public Version Date
October 05, 2018
Public Version Number
3
DI Record Publish Date
October 28, 2016
Package DI Number
08714729839927
Quantity per Package
5
Contains DI Package
08714729848257
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 151 |
| 3 | A medical device with high risk that requires premarket approval | 8 |