SynCardia Companion AC Input Power Cord

Basic Information

• Brand Name: SynCardia Companion AC Input Power Cord
• Primary DI: 00858000003220
• Version / Model: 197053-001
• Company Name: SYNCARDIA SYSTEMS, LLC
• Labeler DUNS: 080414145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-23
• Public Version: 1
• Public Version Date: 2025-05-01
• Public Version Status: New
• Public Device Record Key: 57df2463-e4d9-457d-8230-0e73c5234ac8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOZ	Artificial Heart	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63640	Ventricular prosthesis system, pneumatically-powered	An assembly of devices intended to function as an artificial replacement for failing heart ventricles (end-stage biventricular failure), typically temporarily prior to heart transplantation. It consists of two implanted pneumatically-powered pumping units, with built-in mechanical heart valves, which replace the excised natural heart ventricles and are connected to the heart atria, aorta, and pulmonary arteries; the prosthesis is driven by an external pneumatic pump connected via percutaneous pneumatic drive-lines entering the patient's chest.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858000003220	GS1

Premarket Submissions

Submission Number	Supplement Number
P030011	011
P030011	039