Duns Number:938215568
Device Description: DyeVert Plus EZ Contrast Reduction System
Catalog Number
-
Brand Name
DYEVERT™ PLUS EZ
Version/Model Number
HV-EZ-PRS
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
Yes
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
449dfe38-f3d2-4a38-b55e-14ffc549350b
Public Version Date
October 30, 2019
Public Version Number
2
DI Record Publish Date
November 09, 2018
Package DI Number
00815241020751
Quantity per Package
10
Contains DI Package
00815241020713
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
HV-EZ-PRS-10
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |