Catalog Number

-

Brand Name

LifePort® Kidney Transporter

Version/Model Number

LKT300

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

K021362,K021362

Product Code

KDN

Product Code Name

System, Perfusion, Kidney

Public Device Record Key

5d009bf0-5fe7-417f-b692-e3d753d120f9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 16, 2017

Package DI Number

10815045020060

Quantity per Package

10

Contains DI Package

00815045020049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case