Duns Number:926684994
Device Description: CVi Angiographic Injection System Control Panel, p/n 700771-005
Catalog Number
-
Brand Name
ACIST CVi® Angiographic Injection System Control Panel
Version/Model Number
017738
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 20, 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)
-
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
7dddca59-0213-487c-9b6b-e913e61e42f3
Public Version Date
April 15, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
30841716100629
Quantity per Package
1
Contains DI Package
10841716100625
Package Discontinue Date
February 20, 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 |