Catalog Number

1145

Brand Name

Iradimed

Version/Model Number

1145

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K090087

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

67beed67-8fce-419e-88d1-b23ff1c2f3f7

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

August 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-