Catalog Number

SV-S25FL35C

Brand Name

SURFLO®

Version/Model Number

SV-S25FL35C

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"

Yes

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

K133894,K133894,K133894

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

922ce5c1-00eb-490e-a9d8-5c7825d70c1e

Public Version Date

August 26, 2020

Public Version Number

4

DI Record Publish Date

June 21, 2017

Package DI Number

55413206214919

Quantity per Package

5

Contains DI Package

35413206214915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton