Catalog Number

70106.7950

Brand Name

QUADROX-i

Version/Model Number

Adult, reservoir, filter

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 16, 2017

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"

-

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

K132166

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Public Device Record Key

b5f1e04a-9da0-4720-bbe9-0f5a93b50411

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

December 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-