SynCardia Companion Drivelines

GUDID 00858000003152

SYNCARDIA SYSTEMS, LLC

Ventricular prosthesis system, pneumatically-powered

• Primary Device ID: 00858000003152
• NIH Device Record Key: bdcd3a71-b37f-4f2c-9140-7191659290e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynCardia Companion Drivelines
• Version Model Number: 193002-001
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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 Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858000003152 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-05-29

Devices Manufactured by SYNCARDIA SYSTEMS, LLC

• 00858000003145 - SynCardia Companion Driver Caddy: 2025-06-06
• 00858000003152 - SynCardia Companion Drivelines: 2025-06-06
• 00858000003152 - SynCardia Companion Drivelines: 2025-06-06
• 00858000003244 - SynCardia Freedom® Car Charger: 2025-05-02
• 00858000003251 - SynCardia Freedom® Battery Charger: 2025-05-02
• 00858000003268 - SynCardia Freedom® Power Adaptor: 2025-05-02
• 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