Impella CP with SmartAssist 1000413

GUDID 00813502013566

Impella CP with SmartAssist (Pump 382) pump set

Abiomed, Inc.

Intracardiac circulatory assist axial-pump catheter

• Primary Device ID: 00813502013566
• NIH Device Record Key: bfd2e1cf-d5ba-4e38-ac7d-65e829bc3a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impella CP with SmartAssist
• Version Model Number: 1000413
• Catalog Number: 1000413
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813502013566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140003

FDA Product Code

• OZD: Temporary Non-Roller Type Left Heart Support Blood Pump

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: 2025-11-24
• Device Publish Date: 2025-11-14

Devices Manufactured by Abiomed, Inc.

• 00813502013566 - Impella CP with SmartAssist: 2025-11-24Impella CP with SmartAssist (Pump 382) pump set
• 00813502013566 - Impella CP with SmartAssist: 2025-11-24 Impella CP with SmartAssist (Pump 382) pump set
• 00813502013269 - Abiomed 14Fr Low Profile Introducer: 2024-05-21 Kit, Low Profile, 14Fr, 25cm,Sheath Lock
• 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