Duns Number:926684994
Device Description: Model A2000V, p/n 701259-003Kit Contents: 100mL contrast reservoir and tubing with contras Model A2000V, p/n 701259-003Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp
Catalog Number
-
Brand Name
Multi-use Syringe Kit
Version/Model Number
014113
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
bf078348-a3ec-48a5-a068-12aee1dcd367
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
30841716100087
Quantity per Package
10
Contains DI Package
10841716100083
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 193 |