Catalog Number

LVV-018S

Brand Name

Surge Cardiovascular

Version/Model Number

LVV-018S

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

ac015893-b031-4dad-ac5e-f3dfe5f711ed

Public Version Date

September 21, 2022

Public Version Number

5

DI Record Publish Date

October 27, 2017

Package DI Number

10817278012225

Quantity per Package

20

Contains DI Package

00817278012228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case