Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

35-401076

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

79d939c7-3f91-4653-8799-c490539c2f3e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 26, 2017

Package DI Number

50749756933587

Quantity per Package

100

Contains DI Package

00749756933582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case