Catalog Number

3883

Brand Name

Iradimed

Version/Model Number

3883

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

K172200

Product Code

MWI

Product Code Name

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Public Device Record Key

f517e271-a3f4-45eb-a870-5fb46b7dc1c8

Public Version Date

August 28, 2020

Public Version Number

1

DI Record Publish Date

August 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-