Catalog Number

-

Brand Name

Cardiovascular Procedure Kit

Version/Model Number

66574

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

K823451,K823451

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Public Device Record Key

3f390815-bd00-49bd-9718-e68ecfb5121b

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

October 11, 2017

Package DI Number

50699753506775

Quantity per Package

5

Contains DI Package

00699753506770

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Piece Case