LifeSPARC

GUDID 00814112020647

Power cord for blood pump controller charging station

CARDIACASSIST, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00814112020647
• NIH Device Record Key: cb9008a4-57dd-43f5-a97c-171cf019ea35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeSPARC
• Version Model Number: 5900-0010
• Company DUNS: 948683941
• Company Name: CARDIACASSIST, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 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	00814112020647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183623

FDA Product Code

• DWA: Control, Pump Speed, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-26
• Device Publish Date: 2019-12-18

On-Brand Devices [LifeSPARC]

• 00814112020807: LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Rapid Depolyment Cannula
• 00814112020791: LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Cannula
• 00814112020784: LifeSPARC Blood Pump Kit with 29 Fr ProtekDuo Veno-Venous Cannula
• 00814112020746: LifeSPARC Blood Pump Kit with 72cm Transseptal Cannula and 15Fr Arterial Cannula
• 00814112020739: LifeSPARC Blood Pump Kit with 72cm Transseptal Cannula and 17Fr Arterial Cannula
• 00814112020722: LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 15Fr Arterial Cannula
• 00814112020715: LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 17Fr Arterial Cannula
• 00814112020654: Removable Batteries of LifeSPARC blood pump controller
• 00814112020647: Power cord for blood pump controller charging station
• 00814112020616: LifeSPARC holster, blood pump securement accessory
• 00814112020593: LifeSPARC blood pump kit with accessories
• 00814112020579: Flow Sensor
• 00814112020562: Blood pump controller, charging station, Power cord, flow sensor, removable batteries
• 00814112020814: LifeSPARC Priming Tray Accessory Kit
• 00814112020609: LifeSPARC Priming Tray Kit: LIfeSPARC Blood Pump with TandemLung Oxygenator
• 00814112020906: IV Pole Clamp for blood pump controller
• 00814112020586: Controller Battery
• 00814112020678: LifeSPARC holster, blood pump and oxygenator securement accessory
• 00814112020630: Charging station for blood pump controller
• 00814112020623: Blood pump controller