SynCardia 50cc TAH-t Surgical Spares Kit

GUDID 00858000003091

SYNCARDIA SYSTEMS, LLC

Ventricular prosthesis system, pneumatically-powered

• Primary Device ID: 00858000003091
• NIH Device Record Key: ab8f3865-2dcb-4c55-976d-4b4ec64dbf12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynCardia 50cc TAH-t Surgical Spares Kit
• Version Model Number: 550177-001
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858000003091 [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: 2025-05-01
• Device Publish Date: 2025-04-23

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• 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