Catalog Number

-

Brand Name

DLP®

Version/Model Number

67536

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

K842375,K842375

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

04040b65-846a-48de-9111-0dde5f0b85e4

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

August 19, 2016

Package DI Number

20613994878438

Quantity per Package

10

Contains DI Package

00613994878434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK