Catalog Number

70105.0330

Brand Name

QUADROX-i

Version/Model Number

Pediatric, diffusion, BIOLINE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

3829a310-f8a1-44d8-87a6-2c9d52d9cba8

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

04037691670171

Quantity per Package

4

Contains DI Package

04037691670164

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-