Catalog Number

701067350R03

Brand Name

ECC Small - Cardiac

Version/Model Number

BEQ-TOP 5208

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

3cc0b66e-4fd8-45e9-be6e-0e0f7e665773

Public Version Date

May 23, 2019

Public Version Number

1

DI Record Publish Date

May 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-