Catalog Number

640457

Brand Name

CT Exprès™ - Patient Set

Version/Model Number

640457

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

K151048,K151048

Product Code

IZQ

Product Code Name

Injector, Contrast Medium, Automatic

Public Device Record Key

092771fc-4e98-47b0-a88b-b2acab7f7cc0

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

37630039300013

Quantity per Package

25

Contains DI Package

17630039300019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box