Catalog Number

70104.6977

Brand Name

NA

Version/Model Number

Adaption part

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

K082117,K082117

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

2e1c1bdf-46f6-4b5f-a4aa-3217d16fabbd

Public Version Date

February 03, 2020

Public Version Number

5

DI Record Publish Date

October 24, 2015

Package DI Number

04037691508009

Quantity per Package

20

Contains DI Package

04037691507996

Package Discontinue Date

February 01, 2020

Package Status

Not in Commercial Distribution

Package Type

-