ACIST CVi® Angiographic Injection System - CVi Injector p/n 800620-020Contents: CVi Injector - ACIST MEDICAL SYSTEMS, INC.

Duns Number:926684994

Device Description: CVi Injector p/n 800620-020Contents: CVi Injector Head (Siemens), Bed Mount, & Power Suppl CVi Injector p/n 800620-020Contents: CVi Injector Head (Siemens), Bed Mount, & Power Supply"

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More Product Details

Catalog Number

-

Brand Name

ACIST CVi® Angiographic Injection System

Version/Model Number

014658

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 19, 2018

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

d90f1547-b83f-4944-89bd-5d8ad339bccd

Public Version Date

April 15, 2019

Public Version Number

3

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACIST MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 193