Catalog Number

504LTCHWF-R/C

Brand Name

Merit® Manifold

Version/Model Number

00884450091456

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

7fde139f-47e7-43eb-8881-2877b104817e

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884450091450

Quantity per Package

4

Contains DI Package

10884450091453

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-