Catalog Number

-

Brand Name

Intersept™

Version/Model Number

CB4615

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K171979,K171979

Product Code

DTZ

Product Code Name

OXYGENATOR, CARDIOPULMONARY BYPASS

Public Device Record Key

931ea71b-0538-44b0-b3b6-975befc5a2a6

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

March 01, 2020

Package DI Number

20763000218427

Quantity per Package

10

Contains DI Package

00763000218423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK