Impella 0043-0003
GUDID 00813502011135
Temporary cardiac support blood pump
Abiomed, Inc.
Intracardiac circulatory assist axial-pump catheter| Primary Device ID | 00813502011135 |
| NIH Device Record Key | ddd5664c-0e26-4bc4-aef8-60c28110d9db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Impella |
| Version Model Number | Purge Cassettes |
| Catalog Number | 0043-0003 |
| Company DUNS | 050636737 |
| Company Name | Abiomed, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com | |
| Phone | 978.777.5410 |
| wbolt@abiomed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813502010510 [Unit of Use] |
| GS1 | 00813502011135 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P140003
FDA Product Code
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump |
| PBL | Temporary Cardiac Support Blood Pump |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-07-31 |
On-Brand Devices [Impella]
| 00813502011364 | Impella 2.5 13 FR OEM Introducer Kit |
| 00813502011319 | Temporary cardiac support blood pump |
| 00813502011302 | Impella CP 14 FR Introducer Kit |
| 00813502011289 | Temporary cardiac support blood pump |
| 00813502011258 | Temporary cardiac support blood pump |
| 00813502011227 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| 00813502011210 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| 00813502011180 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| 00813502011173 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| 00813502011142 | Temporary cardiac support blood pump |
| 00813502011135 | Temporary cardiac support blood pump |
| 00813502011128 | Impella Quick Setup Kit MPC |
| 00813502011081 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| 00813502011067 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| 00813502011029 | Right ventricular support device for up to 14 days of support to treat acute right heart failure |
| 00813502010480 | Impella CP Pump Set GWRU |
| 00813502010138 | AB Portable Power Pack, Packaged |
| 00813502010114 | AB Portable Driver, Packaged |
| 00813502010022 | Automated Impella Controller (AIC) |
| 00813502010015 | Impella Axillary Insertion Kit |
| 00081350201002 | Controller for PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| 04260113630327 | Impella LR 0.027" PTFE Guidewire |
| 04260113630310 | Impella LR 0.025" PTFE Guidewire |
| 04260113630303 | Impella LR 0.018" PTFE Guidewire |
| 00813502011371 | Temporary non-roller type left heart support blood pump |
| 00813502011715 | ABMD Introducer Kit, 14Fr x Long, Pkgd |
| 00813502011708 | ABMD Introducer Kit, 14Fr x Short, Pkgd |
| 00813502011661 | KIT, 14Fr INTRODUCER, 25 cm, ABMD |
| 00813502011654 | KIT, 14Fr INTRODUCER, 13 cm, ABMD |
| 00813502011531 | Temporary non-roller type left heart support blood pump |
| 00813502011500 | KIT, 14Fr INTRODUCER, 13&25 cm, ABMD |
| 00813502013252 | Kit, Low Profile, 14Fr, 13cm,Sheath Lock |
| 00813502012996 | Kit, Low Profile, 14Fr, Short, 1UP |
| 04260113630259 | Sterile Connector Cable Pump / IMC |
| 04260113630174 | Impella 5.0 IMC Pump Set EU |
| 00813502013030 | AIC w/Impella Connect for ECP |
| 00813502012828 | Impella 5.5 with Smart Assist S2 Set, US |
| 00813502012460 | Purge Cassette Gen02, 5-Packs |
| 00813502011869 | RP w Smart Assist Set, US |
| 00813502010510 | Purge Cassette, Packaged |
| 00813502012910 | Introducer Kit 23Fr x 11cm |
| 00813502012279 | Pump 381 Pump Set (US) |
| 00813502011876 | Pump 371 14F LT CMR Set |
| 00813502011401 | Optical, AIC, Impella Connect, Pkgd, US |
| 00813502011388 | Impella CP C7 w V3 GWRU Set, US |
| 00813502013474 | Kit, 14Fr Introducer, 13cm and 25cm |
| 00813502012736 | ABMD Intro Kit, 14Fr x Long, Pkgd US |
| 00813502012729 | ABMD Intro Kit, 14Fr x Short, Pkgd US |
Trademark Results [Impella]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMPELLA 98555829 not registered Live/Pending |
Abiomed, Inc. 2024-05-17 |
 IMPELLA 79134516 not registered Dead/Abandoned |
Regal Beloit Australia Pty Ltd 2013-05-22 |
 IMPELLA 75534996 2443683 Live/Registered |
ABIOMED, INC. 1998-08-07 |
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