Catalog Number

-

Brand Name

ClearView MV Atrial Depressor

Version/Model Number

001-400-005

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"

Yes

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

K053021

Product Code

DTS

Product Code Name

Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Public Device Record Key

5f986dab-fbd7-4f11-a066-5647a2cbf72b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-