Catalog Number

RSG-M014S-L

Brand Name

Surge Cardiovascular

Version/Model Number

RSG-M014S-L

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

38d2b2f6-2805-4229-8b0f-53b099599dba

Public Version Date

September 21, 2022

Public Version Number

4

DI Record Publish Date

March 26, 2018

Package DI Number

20817278011539

Quantity per Package

5

Contains DI Package

00817278012167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-