Catalog Number

3910140.001

Brand Name

WAVES/WCM Sterile Drape

Version/Model Number

DRAPE STERILE PACK - 1drape/bag (included in WCM cassettes kit)

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

Yes

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,K111521

Product Code

KDN

Product Code Name

System, Perfusion, Kidney

Public Device Record Key

a510672f-5fec-40e6-899b-2883cc2699bc

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

February 12, 2017

Package DI Number

3910140001

Quantity per Package

6

Contains DI Package

B154W39300050020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case