Catalog Number

51-000031-00

Brand Name

Quantum ®

Version/Model Number

Quantum Workstation 12 inch (QWS12)

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

K181923

Product Code

DRY

Product Code Name

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Public Device Record Key

5e0793a0-9b07-432e-b848-f2fe9e8418b7

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-