Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

35-401087

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"

Yes

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

f0a571b0-6ce2-4c65-81a0-21c9d79e03c0

Public Version Date

April 05, 2018

Public Version Number

1

DI Record Publish Date

March 05, 2018

Package DI Number

50749756948529

Quantity per Package

100

Contains DI Package

00749756948524

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case