Catalog Number

-

Brand Name

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

-

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

K151048,K151048

Product Code

IZQ

Product Code Name

Injector, Contrast Medium, Automatic

Public Device Record Key

df3860fa-6e5e-436c-be6f-62df41e6883d

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Package DI Number

37630039301713

Quantity per Package

25

Contains DI Package

17630039301719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton