Impella

Primary DI
00813502011029
Brand
Impella
Company
Abiomed, Inc.
Model
004334
Catalog number
004334
Device description
Impella RP US Pump Set
Published
2016-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJERight Ventricular Bypass (Assist) Device
PYXTemporary Non-Roller Type Right Heart Support Blood Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJERight Ventricular Bypass (Assist) DeviceUnknownf
PYXTemporary Non-Roller Type Right Heart Support Blood PumpCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H140001000
P170011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H140001000
P170011000Impella RP SystemAbiomed, Inc.2017-09-20PYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813502011029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502011029008135020110298135020110290813502011029

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
Kit
true
Serial number
true
Expiration date on label
true
No natural rubber latex
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
07640135140153CentriMag™Thoratec CorporationOJE2026-02-19
00813502010985ImpellaAbiomed, Inc.PYX2023-08-08
00813502011401ImpellaAbiomed, Inc.PYX2023-07-31
00813502012477ImpellaAbiomed, Inc.PYX2023-06-19
00813502011869ImpellaAbiomed, Inc.PYX2023-06-19
04260113630259Impella Abiomed, Inc.PYX2023-06-19
00813502012811Impella Abiomed, Inc.PYX2023-02-15
00813502010022ImpellaAbiomed, Inc.PYX2016-10-21
07640135140603CENTRIMAG RVAS HDE KITThoratec Switzerland GmbHOJE2014-09-20
00813502011135ImpellaAbiomed, Inc.PYX2014-07-31