Catalog Number

-

Brand Name

NA

Version/Model Number

3J05R14

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

K171308

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Public Device Record Key

dfd7dec0-5adf-480b-a64f-51c66308a739

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-