Catalog Number

709000390

Brand Name

ECLS Accessory Pack

Version/Model Number

BEQ-T 36507

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 23, 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"

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

9a9b6867-a276-4dc4-9421-fb8258ef9ff3

Public Version Date

December 24, 2020

Public Version Number

5

DI Record Publish Date

March 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-