Catalog Number

-

Brand Name

INSPIRE

Version/Model Number

7 DUAL

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

K190690,K190690

Product Code

DTN

Product Code Name

Reservoir, blood, cardiopulmonary bypass

Public Device Record Key

31b3c01e-5d9b-4adc-8842-12acaed20afe

Public Version Date

January 22, 2020

Public Version Number

2

DI Record Publish Date

August 28, 2019

Package DI Number

38033178113237

Quantity per Package

2

Contains DI Package

08033178113236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX