FDA.reportPublic FDA data

SynCardia Companion Driver Shipping Container

Primary DI
00858000003206
Brand
SynCardia Companion Driver Shipping Container
Company
SYNCARDIA SYSTEMS, LLC
Model
397002-001
Published
2025-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LOZArtificial Heart

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOZArtificial HeartUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030011011
P030011013
P030011015
P030011023

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030011011SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)Syncardia Systems, LLC2004-10-15LOZ
P030011013SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)Syncardia Systems, LLC2004-10-15LOZ
P030011015SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)Syncardia Systems, LLC2004-10-15LOZ
P030011023SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)Syncardia Systems, LLC2004-10-15LOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858000003206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858000003206008580000032068580000032060858000003206

GMDN Terms#

Term, Definition table
TermDefinition
Ventricular prosthesis system, pneumatically-poweredAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure500 millibar1060 millibar
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080414145
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858000003305SynCardia Hand Pump Shipping Container397004-0012025-04-24
00858000003015SynCardia Freedom® Standby Kit Shipping Container595510-0012025-04-23
00858000003022SynCardia Freedom® Discharge Kit Shipping Container 595630-0012025-04-23
00858000003213SynCardia Companion Hospital Cart Shipping Container397003-0012025-04-23
00858000003237SynCardia Companion Driver Caddy Shipping Container397001-0012025-04-23
00858000003145SynCardia Companion Driver Caddy397001-0012025-05-29
00858000003152SynCardia Companion Drivelines193002-0012025-05-29
00858000003244SynCardia Freedom® Car Charger295053-0012025-04-24
00858000003251SynCardia Freedom® Battery Charger295054-0012025-04-24
00858000003268SynCardia Freedom® Power Adaptor295070-0012025-04-24
00858000003275SynCardia Freedom® Hospital AC Power Supply295400-0012025-04-24
00858000003282SynCardia Freedom® Home AC Power Supply295600-0012025-04-24
00858000003299SynCardia Freedom® Battery Charger Set Shipping Container395103-0012025-04-24
00858000003046SynCardia 70cc TAH-t Surgical Spares Kit500177-0012025-04-23
00858000003053SynCardia 50cc TAH-t, Clinical570500-0012025-04-23
00858000003091SynCardia 50cc TAH-t Surgical Spares Kit550177-0012025-04-23
00858000003138SynCardia Companion Hospital Cart397003-0012025-04-23
00858000003190SynCardia Companion Battery Shipping Container197603-0012025-04-23
00858000003220SynCardia Companion AC Input Power Cord197053-0012025-04-23
00858000003077SynCardia Companion Rechargeable LI-ION Battery293001-0012015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858000003145SynCardia Companion Driver CaddySYNCARDIA SYSTEMS, LLCLOZ2025-05-29
00858000003152SynCardia Companion DrivelinesSYNCARDIA SYSTEMS, LLCLOZ2025-05-29
00858000003244SynCardia Freedom® Car ChargerSYNCARDIA SYSTEMS, LLCLOZ2025-04-24
00858000003251SynCardia Freedom® Battery ChargerSYNCARDIA SYSTEMS, LLCLOZ2025-04-24
00858000003268SynCardia Freedom® Power AdaptorSYNCARDIA SYSTEMS, LLCLOZ2025-04-24
00858000003275SynCardia Freedom® Hospital AC Power SupplySYNCARDIA SYSTEMS, LLCLOZ2025-04-24
00858000003282SynCardia Freedom® Home AC Power SupplySYNCARDIA SYSTEMS, LLCLOZ2025-04-24
00858000003299SynCardia Freedom® Battery Charger Set Shipping ContainerSYNCARDIA SYSTEMS, LLCLOZ2025-04-24
00858000003305SynCardia Hand Pump Shipping ContainerSYNCARDIA SYSTEMS, LLCLOZ2025-04-24
00858000003015SynCardia Freedom® Standby Kit Shipping ContainerSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003022SynCardia Freedom® Discharge Kit Shipping Container SYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003046SynCardia 70cc TAH-t Surgical Spares KitSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003053SynCardia 50cc TAH-t, ClinicalSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003091SynCardia 50cc TAH-t Surgical Spares KitSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003138SynCardia Companion Hospital CartSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003190SynCardia Companion Battery Shipping ContainerSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003213SynCardia Companion Hospital Cart Shipping ContainerSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003220SynCardia Companion AC Input Power CordSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003237SynCardia Companion Driver Caddy Shipping ContainerSYNCARDIA SYSTEMS, LLCLOZ2025-04-23
00858000003008SynCardia temporary Total Artificial Heart SystemSYNCARDIA SYSTEMS, LLCLOZ2015-10-23
00858000003077SynCardia Companion Rechargeable LI-ION BatterySYNCARDIA SYSTEMS, LLCLOZ2015-10-23
00858000003084SynCardia Freedom® Onboard BatterySYNCARDIA SYSTEMS, LLCLOZ2015-10-23
00858000003107SynCardia Companion 2 Driver SYNCARDIA SYSTEMS, LLCLOZ2015-10-23
00858000003114SynCardia Hand PumpSYNCARDIA SYSTEMS, LLCLOZ2015-10-23
00858000003121SynCardia Freedom® DriverSYNCARDIA SYSTEMS, LLCLOZ2015-10-23