Catalog Number

-

Brand Name

EXCOR® VAD

Version/Model Number

1600190

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

-

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,P160035,P160035

Product Code

DSQ

Product Code Name

Ventricular (Assisst) Bypass

Public Device Record Key

2115dbdf-d4ea-4fea-88ef-18593491e5ae

Public Version Date

October 21, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-