Catalog Number

-

Brand Name

CLS

Version/Model Number

201006-000

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

c0a3fd1b-e430-40b0-9805-22a6a9141102

Public Version Date

November 02, 2020

Public Version Number

4

DI Record Publish Date

June 19, 2018

Package DI Number

10864039000410

Quantity per Package

25

Contains DI Package

00864039000413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-