Catalog Number

701068435

Brand Name

Pedi LVAD Loop

Version/Model Number

BEQ-T 50400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 07, 2021

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

DWE

Product Code Name

Tubing, Pump, Cardiopulmonary Bypass

Public Device Record Key

3942ad5d-6334-4b31-b860-8f7ffd6c7c7c

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

April 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-