Catalog Number

PCHVA08

Brand Name

Prelude Choice™

Version/Model Number

00884450334003

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)

-

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

0d4879b5-6ed2-4f54-9e98-9f63ce2faf82

Public Version Date

November 29, 2018

Public Version Number

1

DI Record Publish Date

October 29, 2018

Package DI Number

10884450334000

Quantity per Package

10

Contains DI Package

00884450334003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-