Catalog Number

193111

Brand Name

Manifold

Version/Model Number

193111

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K915301,K915301

Product Code

DTL

Product Code Name

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Public Device Record Key

e61d4cd6-8b7d-49d3-9993-b530de19dbae

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20886333207002

Quantity per Package

25

Contains DI Package

00886333207008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box