FDA.reportPublic FDA data

Impella

Primary DI
00813502013030
Brand
Impella
Company
Abiomed, Inc.
Model
1000432
Catalog number
1000432
Device description
AIC w/Impella Connect for ECP
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140003000IMPELLA 2.5 SystemAbiomed, Inc.2015-03-23OZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813502013030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502013030008135020130308135020130300813502013030

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac circulatory assist axial-pump catheter control unitA mains electricity (AC-powered) device designed to operate and monitor an intracardiac circulatory assist axial-pump catheter (e.g., a catheter with integrated micro motor and impeller) to provide circulatory assistance to the heart by pumping blood during heart failure. It typically consists of operator controls, a monitoring interface, a low-voltage connection to drive the impeller, a fluid purging pump, and provides backup power when line power is not available during transport. It is typically used emergently [e.g., post acute myocardial infarction (AMI)] or electively when haemodynamic support is necessary.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050636737
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04260113630174ImpellaAbiomed, Inc.OZD2023-06-19
04260113630259Impella Abiomed, Inc.OZD2023-06-19
00813502011531ImpellaAbiomed, Inc.OZD2020-04-15
00813502011371ImpellaAbiomed, Inc.OZD2019-04-18
04260113630303ImpellaAbiomed, Inc.OZD2016-10-21
04260113630310ImpellaAbiomed, Inc.OZD2016-10-21
04260113630327ImpellaAbiomed, Inc.OZD2016-10-21
00813502010022ImpellaAbiomed, Inc.OZD2016-10-21
00813502010114ImpellaAbiomed, Inc.OZD2016-10-21
00813502010138ImpellaAbiomed, Inc.OZD2016-10-21
00813502010480ImpellaAbiomed, Inc.OZD2016-10-21
00813502011302ImpellaAbiomed, Inc.OZD2016-10-21
00813502011364ImpellaAbiomed, Inc.OZD2016-10-21
00081350201002ImpellaAbiomed, Inc.OZD2016-01-20
00813502011258ImpellaAbiomed, Inc.OZD2014-09-09
00813502011081ImpellaAbiomed, Inc.OZD2014-09-03
00813502011135ImpellaAbiomed, Inc.OZD2014-07-31
00813502011142ImpellaAbiomed, Inc.OZD2014-07-31
00813502011180ImpellaAbiomed, Inc.OZD2014-07-31
00813502011289ImpellaAbiomed, Inc.OZD2014-07-31