Catalog Number

70105.3824

Brand Name

NA

Version/Model Number

QUADROX-iD Adult, BIOLINE Coating

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2020

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

K132829,K132829

Product Code

DTR

Product Code Name

HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Public Device Record Key

d152c0bb-53a2-4a03-9ef4-df7964c94cc4

Public Version Date

February 03, 2020

Public Version Number

6

DI Record Publish Date

October 24, 2015

Package DI Number

04037691725079

Quantity per Package

4

Contains DI Package

04037691725062

Package Discontinue Date

February 01, 2020

Package Status

Not in Commercial Distribution

Package Type

-