Catalog Number

-

Brand Name

ACIST CVi® Angiographic Injection System

Version/Model Number

014657

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

-

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

d38b4edc-3f26-449a-94fe-180e5f46f2ae

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-