Catalog Number

MAP952

Brand Name

FLO50™

Version/Model Number

00884450322291

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

cf7e6740-12b7-4833-9611-16698f8651e7

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

February 14, 2018

Package DI Number

20884450322295

Quantity per Package

4

Contains DI Package

10884450322298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-