Catalog Number

-

Brand Name

KMI IMI GROUP

Version/Model Number

SFRT

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

-

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

73c8603d-1c63-47cf-ac6e-8325ffbdae3b

Public Version Date

August 27, 2021

Public Version Number

5

DI Record Publish Date

July 03, 2017

Package DI Number

10851314007202

Quantity per Package

20

Contains DI Package

00851314007205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case