FDA.reportPublic FDA data

Impella

Primary DI
00813502010138
Brand
Impella
Company
Abiomed, Inc.
Model
AB Portable Power Pack, Packaged
Published
2016-10-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OZDTemporary Non-Roller Type Left Heart Support Blood Pump
PBLTemporary Cardiac Support Blood Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZDTemporary Non-Roller Type Left Heart Support Blood PumpUnknown3
PBLTemporary Cardiac Support Blood Pump

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813502010138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502010138008135020101388135020101380813502010138

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac circulatory assist axial-pump catheterA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050636737
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813502013009Abiomed Low Profile Introducer Kit10004352026-01-12
00813502010411Impella RP Flex Introducer Kit20003422026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer Kit0052-3052 2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit 0052-3053 2026-03-11
00813502011678Abiomed Impella14Fr Introducer Kit, 13cm & 25cm0052-30462026-02-25
00813502013566Impella CP with SmartAssist100041310004132025-11-14
00813502010220Impella 14Fr Introducer Kit, long0052-00172025-10-16
00813502010015Impella0052-00110052-00112016-10-21
00813502011173Impella0046830046832014-09-03
00813502012729Impella10005340052-00382023-10-27
00813502012736Impella10005350052-00392023-10-27
00813502011388Impella0048-00320048-00032023-07-31
00813502011371Impella0048-00240048-00032019-04-18
00813502011876Impella0048-00450048-00032023-07-31
00813502013269Abiomed 14Fr Low Profile Introducer100045810004582024-05-13
00813502012279Impella10000800048-00032023-07-31
00813502013474Impella100055010005502023-10-27
00813502012910Impella100044110004412023-06-30
00813502012996Impella100043410004342023-05-31
00813502013252Impella100045710004572023-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813502013566Impella CP with SmartAssistAbiomed, Inc.OZD2025-11-14
00813502010985ImpellaAbiomed, Inc.OZD2023-08-08
00813502011388ImpellaAbiomed, Inc.OZD2023-07-31
00813502011401ImpellaAbiomed, Inc.OZD2023-07-31
00813502011876ImpellaAbiomed, Inc.OZD2023-07-31
00813502012279ImpellaAbiomed, Inc.OZD2023-07-31
00813502012477ImpellaAbiomed, Inc.OZD2023-06-19
00813502010510ImpellaAbiomed, Inc.OZD2023-06-19
00813502012460ImpellaAbiomed, Inc.OZD2023-06-19
00813502012828Impella Abiomed, Inc.OZD2023-06-19
00813502013030ImpellaAbiomed, Inc.OZD2023-06-19
04260113630174ImpellaAbiomed, Inc.OZD2023-06-19
04260113630259Impella Abiomed, Inc.OZD2023-06-19
00813502011531ImpellaAbiomed, Inc.OZD2020-04-15
00813502011371ImpellaAbiomed, Inc.OZD2019-04-18
00813502011319ImpellaAbiomed, Inc.PBL2016-10-24
04260113630303ImpellaAbiomed, Inc.OZD2016-10-21
04260113630303ImpellaAbiomed, Inc.PBL2016-10-21
04260113630310ImpellaAbiomed, Inc.OZD2016-10-21
04260113630310ImpellaAbiomed, Inc.PBL2016-10-21
04260113630327ImpellaAbiomed, Inc.OZD2016-10-21
04260113630327ImpellaAbiomed, Inc.PBL2016-10-21
00813502010015ImpellaAbiomed, Inc.PBL2016-10-21
00813502010022ImpellaAbiomed, Inc.OZD2016-10-21
00813502010022ImpellaAbiomed, Inc.PBL2016-10-21
00813502010114ImpellaAbiomed, Inc.PBL2016-10-21
00813502010114ImpellaAbiomed, Inc.OZD2016-10-21
00813502010480ImpellaAbiomed, Inc.OZD2016-10-21
00813502011128ImpellaAbiomed, Inc.PBL2016-10-21
00813502011302ImpellaAbiomed, Inc.PBL2016-10-21