Catalog Number

-

Brand Name

TRILLIUM™ AFFINITY®NT

Version/Model Number

95249

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K021287,K021287

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Public Device Record Key

95273909-c795-41e7-872b-326dd80ac9d5

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

June 24, 2016

Package DI Number

20721902648759

Quantity per Package

4

Contains DI Package

00721902648755

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK