Catalog Number

215-018

Brand Name

Surge Cardiovascular

Version/Model Number

215-018

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

-

Product Code

KRI

Product Code Name

Accessory Equipment, Cardiopulmonary Bypass

Public Device Record Key

23becc9b-9084-47e4-a641-3a02f12d7fbc

Public Version Date

September 21, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10817278011402

Quantity per Package

25

Contains DI Package

00817278011405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case