Catalog Number

-

Brand Name

INSPIRE

Version/Model Number

6F DUAL PH.I.S.I.O.

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

K121909,K121909

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Public Device Record Key

fc4418f8-360b-4f5f-b1c8-38c9eaa35932

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

May 13, 2015

Package DI Number

38033178112414

Quantity per Package

2

Contains DI Package

08033178112413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX