Duns Number:938215568
Device Description: The device consists of a Smart Monitor to be used with the DyeVert or DyeTect systems duri The device consists of a Smart Monitor to be used with the DyeVert or DyeTect systems during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.
Catalog Number
-
Brand Name
Smart Monitor
Version/Model Number
SMART
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
d54c8101-a6f0-4de9-ada9-d547d8cd75b7
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
00815241020836
Quantity per Package
1
Contains DI Package
00815241020829
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SMART-US
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |