Catalog Number

60-1L33

Brand Name

DeRoyal

Version/Model Number

60-1L33

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)

Yes

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

f88fc711-8342-4911-b216-97014a7da3f7

Public Version Date

July 01, 2021

Public Version Number

1

DI Record Publish Date

June 23, 2021

Package DI Number

50749756719631

Quantity per Package

400

Contains DI Package

00749756719636

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case