SynCardia Companion Driver Caddy Shipping Container

GUDID 00858000003237

SYNCARDIA SYSTEMS, LLC

Ventricular prosthesis system, pneumatically-powered

• Primary Device ID: 00858000003237
• NIH Device Record Key: 4d061622-fefa-49b0-8786-25f0bbee8906
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynCardia Companion Driver Caddy Shipping Container
• Version Model Number: 297043-001
• 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: false
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858000003237 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-01
• Device Publish Date: 2025-04-23

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• 00858000003275 - SynCardia Freedom® Hospital AC Power Supply: 2025-05-02
• 00858000003282 - SynCardia Freedom® Home AC Power Supply: 2025-05-02
• 00858000003299 - SynCardia Freedom® Battery Charger Set Shipping Container: 2025-05-02
• 00858000003305 - SynCardia Hand Pump Shipping Container: 2025-05-02
• 00858000003015 - SynCardia Freedom® Standby Kit Shipping Container: 2025-05-01