Catalog Number

0048-0003.0814

Brand Name

Impella

Version/Model Number

Impella CP Pump Set

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2016

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

-

Product Code

OZD

Product Code Name

Temporary Non-Roller Type Left Heart Support Blood Pump

Public Device Record Key

d89802eb-5ed2-4527-946f-c00ab16de0c9

Public Version Date

May 10, 2022

Public Version Number

3

DI Record Publish Date

July 31, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-