Catalog Number

70105.4265

Brand Name

NA

Version/Model Number

Venous Reservoir Bag 800 ml

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

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090690,K090690

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Public Device Record Key

aa732453-ae29-4fab-970a-15434830d339

Public Version Date

February 03, 2020

Public Version Number

6

DI Record Publish Date

October 24, 2015

Package DI Number

04037691740331

Quantity per Package

10

Contains DI Package

04037691740348

Package Discontinue Date

February 01, 2020

Package Status

Not in Commercial Distribution

Package Type

-