FDA.reportPublic FDA data

SynCardia Hand Pump

Primary DI
00858000003114
Brand
SynCardia Hand Pump
Company
SYNCARDIA SYSTEMS, LLC
Model
397004-001
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
P030011022
P030011023
P030011027

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
P030011022SYNCARDIA 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
P030011027SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)Syncardia Systems, LLC2004-10-15LOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858000003114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858000003114008580000031148580000031140858000003114

GMDN Terms#

Term, Definition table
TermDefinition
Artificial heart, temporaryA sterile prosthetic device implanted in the thorax or abdomen that typically consists of an implantable metallic and plastic mechanism that includes one or more pumps working as artificial ventricles to circulate blood, and an electrical or air driven external power unit that is connected to the pumps through transcutaneous electrical wires or pneumatic drive-lines entering the patient's chest. The power unit is attached to the patient and includes a battery and/or a pneumatic console. This device is used mostly as a bridge to heart transplantation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8667719437XX@XX.XX

Regulatory Flags#

DUNS number
080414145
Device count
1
Kit
true
Lot or batch
true
Serial number
true

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
00858000003206SynCardia Companion Driver Shipping Container397002-0012025-04-23
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

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
00858000003206SynCardia Companion Driver 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
00858000003121SynCardia Freedom® DriverSYNCARDIA SYSTEMS, LLCLOZ2015-10-23