Impella® 23F x 30cm Sheath 0052-3069

GUDID 00813502011791

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 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 Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00813502011791
• NIH Device Record Key: beaa920a-7f2b-48f9-9f65-afad074bda7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impella® 23F x 30cm Sheath
• Version Model Number: ABMD 23Fr X 30cm Introducer Kit
• Catalog Number: 0052-3069
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813502011791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201116

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: 2020-07-28
• Device Publish Date: 2020-07-20

Devices Manufactured by Abiomed, Inc.

• 00813502012729 - Impella: 2023-11-06 ABMD Intro Kit, 14Fr x Short, Pkgd US
• 00813502012736 - Impella: 2023-11-06 ABMD Intro Kit, 14Fr x Long, Pkgd US
• 00813502013474 - Impella: 2023-11-06 Kit, 14Fr Introducer, 13cm and 25cm
• 00813502011388 - Impella: 2023-08-08 Impella CP C7 w V3 GWRU Set, US
• 00813502011401 - Impella: 2023-08-08 Optical, AIC, Impella Connect, Pkgd, US
• 00813502011876 - Impella: 2023-08-08 Pump 371 14F LT CMR Set
• 00813502012279 - Impella: 2023-08-08 Pump 381 Pump Set (US)
• 00813502012910 - Impella: 2023-07-10 Introducer Kit 23Fr x 11cm