FDA.reportPublic FDA data

Impella

Primary DI
00813502010510
Brand
Impella
Company
Abiomed, Inc.
Model
0043-0002
Catalog number
0043-0002
Device description
Purge Cassette, Packaged
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
00813502010510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502010510008135020105108135020105100813502010510

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.

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
false
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
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
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