Catalog Number

IM-AFTD

Brand Name

KMI IMI GROUP

Version/Model Number

AFTD

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"

Yes

For Single-Use

Yes

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

cf102cf7-15bd-4cf7-a69c-f2128cc99a64

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

March 23, 2017

Package DI Number

10851314007141

Quantity per Package

10

Contains DI Package

00851314007144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case