Impella

Basic Information

• Brand Name: Impella
• Primary DI: 00813502011180
• Version / Model: Impella 5.0 AIC Pump Set
• Catalog Number: 005062
• Company Name: Abiomed, Inc.
• Labeler DUNS: 050636737
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-07-31
• Public Version: 3
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: 2f874fba-08ed-4b69-ad5c-0ae777c2f439
• Distribution End Date: 2022-10-04

Device Description

PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	870.4360	2
OZD	Temporary Non-Roller Type Cardiac Support Blood Pump	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
56732	Intracardiac circulatory assist axial-pump catheter	A sterile tubular device with a built-in electrically-powered axial flow pump (e.g., a micro motor with an impeller) at the distal end, designed to provide circulatory assistance to the heart by pumping blood during heart failure. It is inserted through the lumen of the aorta and into the left ventricle, surgically or percutaneously via an artery, and connected to an external control unit; it moves blood from the left ventricle to the aorta across the aortic valve. It is typically used emergently post acute myocardial infarction (AMI), electively for high-risk cardiac catheterization, for open chest surgery, and during transport between hospitals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813502011180	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]