Catalog Number

-

Brand Name

Affinity™

Version/Model Number

S4014

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

-

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

-

FDA Premarket Submission

K071253,K071253

Product Code

DTM

Product Code Name

Filter, blood, cardiopulmonary bypass, arterial line

Public Device Record Key

e696d106-dd46-4841-b620-558665ce4a43

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 27, 2017

Package DI Number

20643169858910

Quantity per Package

4

Contains DI Package

00643169858916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK