Duns Number:926684994
Device Description: A2000 Multi-use Syringe Kit, p/n 701669-001Kit Contents: 100mL contrast reservoir and tubi A2000 Multi-use Syringe Kit, p/n 701669-001Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps
Catalog Number
-
Brand Name
A2000 Multi-use Syringe Kit
Version/Model Number
014612
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171646,K171646
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
26c274ac-015c-4726-93dd-788bf5cc4b3f
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
June 06, 2018
Package DI Number
30841716101947
Quantity per Package
10
Contains DI Package
10841716101943
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 |