Catalog Number

709000454

Brand Name

S-Quadrox iD Plain Pack with Rotaflow Bioline

Version/Model Number

BEQ-TOP 8072

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"

Yes

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

-

Product Code

DWE

Product Code Name

Tubing, Pump, Cardiopulmonary Bypass

Public Device Record Key

1bee8e19-a3bf-471c-9447-58e5a687e2ff

Public Version Date

December 02, 2019

Public Version Number

3

DI Record Publish Date

May 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-