Catalog Number

-

Brand Name

Accessories

Version/Model Number

Temperature Probe Kids

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

-

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

K071318

Product Code

DTQ

Product Code Name

CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Public Device Record Key

472ebd4b-364e-4cec-b8d6-08391aaa36be

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-