Catalog Number

3930140.007

Brand Name

WAVES Transport Bag

Version/Model Number

WAVES Transport Bag

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111521

Product Code

KDN

Product Code Name

System, Perfusion, Kidney

Public Device Record Key

a947301b-07f6-4a00-aaba-1892d1766d3c

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

February 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-