Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

77-401010

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

K112458,K112458

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

8e3762f7-32ca-4c54-bb95-09401268fc44

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

50749756823864

Quantity per Package

50

Contains DI Package

00749756823869

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case