Catalog Number

-

Brand Name

LifePort® Kidney Transporter

Version/Model Number

UCAN0005

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)

Yes

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

KDL

Product Code Name

Set, Perfusion, Kidney, Disposable

Public Device Record Key

16ec2f63-1ed7-45f3-a530-64e56ee7388a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 16, 2017

Package DI Number

20815045020241

Quantity per Package

5

Contains DI Package

00815045020223

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case