Home GUDID 00814112020692 TandemLife LifeSPARC
Primary DI 00814112020692
Brand TandemLife LifeSPARC
Company CARDIACASSIST, INC.
Model 5840-2417
Device description LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories
Published 2020-06-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DRE Dilator, Vessel, For Percutaneous Catheterization DTZ Oxygenator, Cardiopulmonary Bypass DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KRI Accessory Equipment, Cardiopulmonary Bypass QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular 2 DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular 2 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular 2 KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular 2 KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular 1 QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00814112020692 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00814112020692 00814112020692 814112020692 0814112020692
GMDN Terms# Term, Definition table Term Definition Cardiopulmonary bypass system centrifugal pump A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.
Regulatory Flags# DUNS number 948683941 Device count 1 Kit true Serial number true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00803622104091 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104107 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104114 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104121 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104138 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104145 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104152 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104169 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622105692 Venous cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104176 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104183 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104190 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104206 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104213 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104220 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104237 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104244 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104251 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104268 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104275 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104282 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104299 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104305 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104312 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104329 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104336 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104343 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104350 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104367 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104374 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17
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