SynCardia Companion 2 Driver

GUDID 00858000003107

SYNCARDIA SYSTEMS, LLC

Artificial heart, temporary

• Primary Device ID: 00858000003107
• NIH Device Record Key: 6c33b8bd-d326-41d5-826e-0000a3ad9faf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynCardia Companion 2 Driver
• Version Model Number: 397002-001
• Company DUNS: 080414145
• Company Name: SYNCARDIA SYSTEMS, LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• 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: 8667719437
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858000003107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030011

FDA Product Code

• LOZ: Artificial Heart

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-23

Devices Manufactured by SYNCARDIA SYSTEMS, LLC

• 00858000003008 - SynCardia temporary Total Artificial Heart System: 2018-07-06
• 00858000003077 - SynCardia Companion Rechargeable LI-ION Battery: 2018-07-06
• 00858000003084 - SynCardia Freedom® Onboard Battery: 2018-07-06
• 00858000003107 - SynCardia Companion 2 Driver: 2018-07-06
• 00858000003107 - SynCardia Companion 2 Driver: 2018-07-06
• 00858000003114 - SynCardia Hand Pump: 2018-07-06
• 00858000003121 - SynCardia Freedom® Driver: 2018-07-06