Duns Number:926684994
Device Description: A2000 Multi-use Syringe Kit, p/n 701277-004Kit Contents: 100mL contrast reservoir and tubi A2000 Multi-use Syringe Kit, p/n 701277-004Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp
Catalog Number
-
Brand Name
A2000 Multi-use Syringe Kit
Version/Model Number
014612
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 27, 2019
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
484d59e9-efaf-46c7-ac7a-a74290de8e8b
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
30841716101268
Quantity per Package
10
Contains DI Package
10841716101264
Package Discontinue Date
February 27, 2019
Package Status
Not 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 |