Impella RP Flex with SmartAssist

GUDID 00813502012811

Abiomed, Inc.

Intracardiac circulatory assist axial-pump catheter

• Primary Device ID: 00813502012811
• NIH Device Record Key: 966a3eaf-e5f9-4f6e-ae48-7389f9d1085a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impella RP Flex with SmartAssist
• Version Model Number: 1000323
• 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: 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	00813502012811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170011

FDA Product Code

• PYX: Temporary Non-Roller Type Right 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: 2023-02-23
• Device Publish Date: 2023-02-15

Devices Manufactured by Abiomed, Inc.

• 00813502010411 - Impella RP Flex Introducer Kit: 2026-03-19 Impella RP Flex Introducer Kit, 23Fr x 11cm
• 00813502011685 - Abiomed Impella CP 14Fr Introducer Kit: 2026-03-19 Abiomed Impella CP 14Fr Introducer Kit, short (13cm)
• 00813502011692 - Abiomed Impella CP 14Fr Introducer Kit: 2026-03-19 Abiomed Impella CP 14Fr Introducer Kit, Long (25cm)
• 00813502011678 - Abiomed Impella14Fr Introducer Kit, 13cm & 25cm: 2026-03-05 Abiomed Impella14Fr Introducer Kit, 13cm & 25cm
• 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