Impella® 23F x 6cm Axillary Sheath 0052-3068

GUDID 00813502011784

Abiomed, Inc.

Intracardiac circulatory assist axial-pump catheter

• Primary Device ID: 00813502011784
• NIH Device Record Key: 09e9b6f4-1694-458a-90da-343f5f3fa246
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impella® 23F x 6cm Axillary Sheath
• Version Model Number: Kit, 23Fr Axillary Introducer, 6cm, ABMD
• Catalog Number: 0052-3068
• 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	00813502011784 [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.

• 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
• 00813502012279 - Impella: 2023-08-08 Pump 381 Pump Set (US)