Catalog Number

-

Brand Name

LifeSPARC

Version/Model Number

5800-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

K153295,K183623

Product Code

DTZ

Product Code Name

Oxygenator, Cardiopulmonary Bypass

Public Device Record Key

2e41ff5f-9cbf-4226-a0a5-10e4178f11d6

Public Version Date

June 08, 2020

Public Version Number

1

DI Record Publish Date

May 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-