Catalog Number

201LTCHF-R/D

Brand Name

Merit® Manifold

Version/Model Number

00884450312216

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

6af5985f-8fae-45a7-a0ba-7b52a3ee202b

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

July 23, 2018

Package DI Number

20884450312210

Quantity per Package

4

Contains DI Package

10884450312213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-