FDA.reportPublic FDA data

Impella

Primary DI
04260113630303
Brand
Impella
Company
Abiomed, Inc.
Model
0052-3005
Catalog number
0052-3005
Device description
"Guide Wire 0.018"" PTFE coated"
Published
2016-10-21
Public version status
Update
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
DQXWire, Guide, Catheter
OZDTemporary Non-Roller Type Left Heart Support Blood Pump
PBLTemporary Cardiac Support Blood Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
OZDTemporary Non-Roller Type Left Heart Support Blood PumpUnknown3
PBLTemporary Cardiac Support Blood Pump

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260113630303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260113630303042601136303034260113630303

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
00813502010220Impella 14Fr Introducer Kit, long0052-00172025-10-16
00813502013009Abiomed Low Profile Introducer Kit10004352026-01-12
00813502010411Impella RP Flex Introducer Kit20003422026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer Kit0052-30522026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit0052-30532026-03-11
00813502011678Abiomed Impella14Fr Introducer Kit, 13cm & 25cm0052-30462026-02-25
00813502013269Abiomed 14Fr Low Profile Introducer100045810004582024-05-13
00813502012729Impella10005340052-00382023-10-27
00813502012736Impella10005350052-00392023-10-27
00813502013474Impella100055010005502023-10-27
00813502012910Impella100044110004412023-06-30
00813502012996Impella100043410004342023-05-31
00813502013252Impella100045710004572023-05-31
00813502011791Impella0052-30690052-30692020-07-20
00813502011708Impella0052-00380052-00382020-04-15
00813502011715Impella0052-00390052-00392020-04-15
00813502010015Impella0052-00110052-00112016-10-21
00813502011302Impella0052-00010052-00012016-10-21
00813502011319Impella0052-00020052-00022016-10-24
00813502011364Impella0052-00070052-00072016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812013030376Instylla GuidewireINSTYLLA INC.DQX2026-11-04
0086001030638335 Helix GuidewirePIRAEUS MEDICAL INC.DQX2026-10-30
30801902124921ARROWTELEFLEX INCORPORATEDDQX2026-10-13
07540184010127OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDQX2026-09-30
07540184020034OptoMOnitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDQX2026-09-30
07540184020058OptoMonitorOpsens IncDQX2026-09-30
07540184020065OptoMonitorOpsens IncDQX2026-09-30
07540184020072OptoMonitorOpsens IncDQX2026-09-30
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
10801902226614ARROWTELEFLEX INCORPORATEDDQX2026-08-28
00884450529300SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529713SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529829SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450590010SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450631928InQwire® AmplatzMerit Medical Systems, Inc.DQX2026-08-21
00884450731789InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00884450739709InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQX2026-02-24
00818075010233AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010264AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00813502010985ImpellaAbiomed, Inc.OZD2023-08-08
00813502011401ImpellaAbiomed, Inc.OZD2023-07-31
10801902202984ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902203073ARROWTELEFLEX INCORPORATEDDQX2023-06-06
B090SPN10050SPINRZien Medical Technologies, LLCDQX2023-05-03
10801902213812ARROWTELEFLEX INCORPORATEDDQX2023-01-06