Catalog Number

70106.7829

Brand Name

QUADROX-i

Version/Model Number

Adult, Filter; BIOLINE Coating

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150267,K150267

Product Code

DTM

Product Code Name

Filter, blood, cardiopulmonary bypass, arterial line

Public Device Record Key

baa5a05b-b96d-4a21-a80d-1f689d4be9be

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

December 15, 2015

Package DI Number

04037692010570

Quantity per Package

4

Contains DI Package

04037692009710

Package Discontinue Date

February 16, 2017

Package Status

Not in Commercial Distribution

Package Type

-