TandemLife LifeSPARC

GUDID 00814112020685

LifeSPARC Blood Pump, TandemLung Oxygenator 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: 00814112020685
• NIH Device Record Key: 2fb9e1a0-59bb-4982-aa8b-1bae5da44d49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TandemLife LifeSPARC
• Version Model Number: 5840-0000
• 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: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com
• Phone: 18003737421
• Email: tl.regulatory@livanova.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020685 [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 [TandemLife LifeSPARC]

• 00814112020685: LifeSPARC Blood Pump, TandemLung Oxygenator and accessories
• 00814112020708: LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and a
• 00814112020692: LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and a