Catalog Number

FEM-V1028

Brand Name

Surge Cardiovascular

Version/Model Number

FEM-V1028

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

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

ba337673-57c8-4eea-97e1-a3db6035ec94

Public Version Date

September 21, 2022

Public Version Number

4

DI Record Publish Date

October 30, 2017

Package DI Number

00817278012631

Quantity per Package

1

Contains DI Package

00817278012389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case