Impella 004683

GUDID 00813502011173

PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Abiomed, Inc.

Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter
Primary Device ID00813502011173
NIH Device Record Key966ee72d-16a1-48da-9c4d-a93acad2038b
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpella
Version Model NumberImpella 5.0 MPC Pump Set
Catalog Number004683
Company DUNS050636737
Company NameAbiomed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813502011173 [Primary]

FDA Product Code

KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-03

On-Brand Devices [Impella]

00813502011364Impella 2.5 13 FR OEM Introducer Kit
00813502011319Temporary cardiac support blood pump
00813502011302Impella CP 14 FR Introducer Kit
00813502011289Temporary cardiac support blood pump
00813502011258Temporary cardiac support blood pump
00813502011227PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00813502011210PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00813502011180PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00813502011173PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00813502011142Temporary cardiac support blood pump
00813502011135Temporary cardiac support blood pump
00813502011128Impella Quick Setup Kit MPC
00813502011081PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00813502011067PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00813502011029Right ventricular support device for up to 14 days of support to treat acute right heart failure
00813502010480Impella CP Pump Set GWRU
00813502010138AB Portable Power Pack, Packaged
00813502010114AB Portable Driver, Packaged
00813502010022Automated Impella Controller (AIC)
00813502010015Impella Axillary Insertion Kit
00081350201002Controller for PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
04260113630327Impella LR 0.027" PTFE Guidewire
04260113630310Impella LR 0.025" PTFE Guidewire
04260113630303Impella LR 0.018" PTFE Guidewire
00813502011371Temporary non-roller type left heart support blood pump
00813502011715ABMD Introducer Kit, 14Fr x Long, Pkgd
00813502011708ABMD Introducer Kit, 14Fr x Short, Pkgd
00813502011661KIT, 14Fr INTRODUCER, 25 cm, ABMD
00813502011654KIT, 14Fr INTRODUCER, 13 cm, ABMD
00813502011531Temporary non-roller type left heart support blood pump
00813502011500KIT, 14Fr INTRODUCER, 13&25 cm, ABMD
00813502013252Kit, Low Profile, 14Fr, 13cm,Sheath Lock
00813502012996Kit, Low Profile, 14Fr, Short, 1UP
04260113630259Sterile Connector Cable Pump / IMC
04260113630174Impella 5.0 IMC Pump Set EU
00813502013030AIC w/Impella Connect for ECP
00813502012828Impella 5.5 with Smart Assist S2 Set, US
00813502012460Purge Cassette Gen02, 5-Packs
00813502011869RP w Smart Assist Set, US
00813502010510Purge Cassette, Packaged
00813502012910Introducer Kit 23Fr x 11cm
00813502012279Pump 381 Pump Set (US)
00813502011876Pump 371 14F LT CMR Set
00813502011401Optical, AIC, Impella Connect, Pkgd, US
00813502011388Impella CP C7 w V3 GWRU Set, US
00813502013474Kit, 14Fr Introducer, 13cm and 25cm
00813502012736ABMD Intro Kit, 14Fr x Long, Pkgd US
00813502012729ABMD Intro Kit, 14Fr x Short, Pkgd US

Trademark Results [Impella]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMPELLA
IMPELLA
79134516 not registered Dead/Abandoned
Regal Beloit Australia Pty Ltd
2013-05-22
IMPELLA
IMPELLA
75534996 2443683 Live/Registered
ABIOMED, INC.
1998-08-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.