Catalog Number

701020721

Brand Name

Cardiohelp

Version/Model Number

MTK 20-554 Medex LogiCal Transducer Holder

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

K102726

Product Code

DTQ

Product Code Name

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Public Device Record Key

55b4289d-b2ef-491c-a503-8337de5f3d6b

Public Version Date

October 08, 2021

Public Version Number

1

DI Record Publish Date

September 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-