AB5000 0055-1232-SV

GUDID 00813502010381

Ventricular (Assist) Bypass

Abiomed, Inc.

Implantable ventricular circulatory assist system

• Primary Device ID: 00813502010381
• NIH Device Record Key: faede470-bb84-4f76-b3e4-02c331fd6110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AB5000
• Version Model Number: AB Pump Set 12mm/32 Apical (Sil)
• Catalog Number: 0055-1232-SV
• 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

Customer Support Contacts

• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com
• Phone: 978.777.5410
• Email: wbolt@abiomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813502010381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P900023

FDA Product Code

• DSQ: Ventricular (Assisst) Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-07-31

On-Brand Devices [AB5000]

• 00813502010848: Ventricular (Assist) Bypass
• 00813502010831: Ventricular (Assist) Bypass
• 00813502010817: Ventricular (Assist) Bypass
• 00813502010800: Ventricular (Assist) Bypass
• 00813502010794: Ventricular (Assist) Bypass
• 00813502010787: Ventricular (Assist) Bypass
• 00813502010770: Ventricular (Assist) Bypass
• 00813502010763: Ventricular (Assist) Bypass
• 00813502010756: Ventricular (Assist) Bypass
• 00813502010749: Ventricular (Assist) Bypass
• 00813502010732: Ventricular (Assist) Bypass
• 00813502010725: Ventricular (Assist) Bypass
• 00813502010718: Ventricular (Assist) Bypass
• 00813502010701: Ventricular (Assist) Bypass
• 00813502010695: Ventricular (Assist) Bypass
• 00813502010688: Ventricular (Assist) Bypass
• 00813502010671: Ventricular (Assist) Bypass
• 00813502010404: Ventricular (Assist) Bypass
• 00813502010398: Ventricular (Assist) Bypass
• 00813502010381: Ventricular (Assist) Bypass
• 00813502010374: Ventricular (Assist) Bypass
• 00813502010367: Ventricular (Assist) Bypass
• 00813502010350: Ventricular (Assist) Bypass
• 00813502010343: Ventricular (Assist) Bypass
• 00813502010336: Ventricular (Assist) Bypass
• 00813502010329: Ventricular (Assist) Bypass
• 00813502010312: Ventricular (Assist) Bypass
• 00813502010305: Ventricular (Assist) Bypass
• 00813502010299: Ventricular (Assist) Bypass
• 00813502010282: Ventricular (Assist) Bypass
• 00813502010275: Ventricular (Assist) Bypass
• 00813502010268: Ventricular (Assist) Bypass
• 00813502010251: Ventricular (Assist) Bypass