FDA.reportPublic FDA data

Impella

Primary DI
00813502012477
Brand
Impella
Company
Abiomed, Inc.
Model
1000200
Catalog number
1000200
Device description
Purge Cassette Gen02, 5-Packs
Published
2023-06-19
Public version status
New
Distribution status
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
PYXTemporary Non-Roller Type Right Heart Support Blood Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZDTemporary Non-Roller Type Left Heart Support Blood PumpUnknown3
PYXTemporary Non-Roller Type Right Heart Support Blood PumpCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140003078
P170011031

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140003078IMPELLA 2.5 SystemAbiomed, Inc.2015-03-23OZD
P170011031Impella RP SystemAbiomed, Inc.2017-09-20PYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813502012477PrimaryGS10
00813502012460Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502012477008135020124778135020124770813502012477
00813502012460008135020124608135020124600813502012460

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump cassetteA sterile device designed to be used in conjunction with an infusion pump or a device containing an infusion pump (e.g., a physiology-monitoring sedation system, physiology-monitoring anaesthesia system), for the delivery of an intravenous (IV) medication (e.g., a sedative or anaesthetic) contained within an independent drug vial. The cassette is inserted into the infusion pump and the drug vial is inserted into the cassette; the cassette tubing interfaces with the pump drive mechanism for medication delivery through connection with an infusion administration set. This is a single-use device.

Regulatory Flags#

DUNS number
050636737
Device count
5
Kit
true
Lot or batch
true
Serial number
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.PYX2023-08-08
00813502010985ImpellaAbiomed, Inc.OZD2023-08-08
00813502011388ImpellaAbiomed, Inc.OZD2023-07-31
00813502011401ImpellaAbiomed, Inc.OZD2023-07-31
00813502011401ImpellaAbiomed, Inc.PYX2023-07-31
00813502011876ImpellaAbiomed, Inc.OZD2023-07-31
00813502012279ImpellaAbiomed, Inc.OZD2023-07-31
00813502010510ImpellaAbiomed, Inc.OZD2023-06-19
00813502011869ImpellaAbiomed, Inc.PYX2023-06-19
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
04260113630259Impella Abiomed, Inc.PYX2023-06-19
00813502012811Impella Abiomed, Inc.PYX2023-02-15
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
00813502010022ImpellaAbiomed, Inc.PYX2016-10-21
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