Catalog Number

FLO40XR

Brand Name

FLO40XR™

Version/Model Number

00884450324981

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

3b145d9c-724d-4039-aa60-6ea49e90d868

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

March 02, 2018

Package DI Number

10884450324988

Quantity per Package

20

Contains DI Package

00884450324981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-