Catalog Number

104305

Brand Name

CONSOLE STANDOFF

Version/Model Number

104305

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KFM

Product Code Name

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Public Device Record Key

91ee0347-5130-44ff-90bf-e9905d4102a1

Public Version Date

May 10, 2021

Public Version Number

6

DI Record Publish Date

September 20, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-