Catalog Number

70102.4254

Brand Name

NA

Version/Model Number

Venous Reservoir Bag 1900 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

K070605,K070605

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Public Device Record Key

0c718913-1cef-4c28-993e-670566c81430

Public Version Date

February 03, 2020

Public Version Number

6

DI Record Publish Date

October 24, 2015

Package DI Number

04037691017433

Quantity per Package

10

Contains DI Package

04037691064819

Package Discontinue Date

February 01, 2020

Package Status

Not in Commercial Distribution

Package Type

-