Catalog Number

-

Brand Name

EXCOR® VAD

Version/Model Number

P15P-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

H100004,H100004,H100004,H100004,H100004,H100004,H100004,H100004,H100004,H100004,H100004,H100004,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035,P160035

Product Code

DSQ

Product Code Name

Ventricular (Assisst) Bypass

Public Device Record Key

e4044dc1-8143-4b45-ad84-d9a62e168c6b

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-