TandemLung LifeSPARC

GUDID 00814112020777

LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous Rapid Deployment cannula and accessories

CARDIACASSIST, INC.

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 00814112020777
• NIH Device Record Key: 3c31bd48-fc78-4b76-b6c5-9b3156e0a1ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TandemLung LifeSPARC
• Version Model Number: 5830-3631
• Company DUNS: 948683941
• Company Name: CARDIACASSIST, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com
• Phone: +14129637770
• Email: tl.regulatory@livanova.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020777 [Primary]

FDA Product Code

• KRI: Accessory Equipment, Cardiopulmonary Bypass

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: 2020-06-08
• Device Publish Date: 2020-05-29

On-Brand Devices [TandemLung LifeSPARC]

• 00814112020777: LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous Rapid Deployment cannul
• 00814112020760: LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous cannula and accessories
• 00814112020753: LifeSPARC Blood Pump, TandemLung Oxygenator, 29 Fr ProtekDuo Veno-Venous cannula and accessories