Catalog Number

-

Brand Name

CARDIOTOMY RESERVOIR

Version/Model Number

FILTERED

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

K902437,K902437

Product Code

DTP

Product Code Name

Defoamer, cardiopulmonary bypass

Public Device Record Key

391509d7-3103-4561-81a9-e22f0cfb3fc4

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

July 15, 2015

Package DI Number

38033178250376

Quantity per Package

6

Contains DI Package

08033178250375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX