Catalog Number

0048-0024

Brand Name

Impella

Version/Model Number

Impella CP with SmartAssist

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

P140003

Product Code

OZD

Product Code Name

Temporary Non-Roller Type Left Heart Support Blood Pump

Public Device Record Key

85036f89-57ca-4b0f-b751-e2d69a9ba4b5

Public Version Date

April 26, 2019

Public Version Number

1

DI Record Publish Date

April 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-