Impella 1000535

GUDID 00813502012736

ABMD Intro Kit, 14Fr x Long, Pkgd US

Abiomed, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00813502012736
• NIH Device Record Key: 37186d87-b8b9-42ff-993e-f4dc77bfd2d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impella
• Version Model Number: 1000535
• Catalog Number: 1000535
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813502012736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222113

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-06
• Device Publish Date: 2023-10-27

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