Impella RP Flex with SmartAssist

GUDID 00813502012811

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 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

• 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.

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• 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