Catalog Number

-

Brand Name

NA

Version/Model Number

11C84R

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,K171308

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Public Device Record Key

b18cf7a3-4460-43bc-a1db-c79393689afa

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 02, 2019

Package DI Number

20763000320465

Quantity per Package

5

Contains DI Package

00763000320454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK