Catalog Number

51-000080-00

Brand Name

Quantum

Version/Model Number

Quantum Workstation Lite (QWSL)

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

K173834

Product Code

DTQ

Product Code Name

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Public Device Record Key

269b602c-8b2e-4d7d-b5d9-fda67ee341f8

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

July 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-