LifeSPARC

Basic Information

• Brand Name: LifeSPARC
• Primary DI: 00814112020722
• Version / Model: 5810-6215
• Company Name: CARDIACASSIST, INC.
• Labeler DUNS: 948683941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-18
• Public Version: 3
• Public Version Date: 2023-03-13
• Public Version Status: Update
• Public Device Record Key: 967b933d-0bb6-4999-b5ac-3d5f578bf1c8

Device Description

LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 15Fr Arterial Cannula

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	870.4200	1
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	870.4360	2
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	Cardiovascular	870.4100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36373	Cardiopulmonary bypass system mounting unit	A platform upon which modular devices of a cardiopulmonary bypass system (e.g., the blood pumps) are mounted to form the complete system. It typically includes electronics and control panels (e.g., microprocessors to control pump speed), and the main connection to the source of line power. It serves as the basic workstation for the operator to monitor and control the system's functions.	No	Active
31718	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.	No	Active
46849	Circulatory assist transseptal cannula	A sterile tubular device designed for cannulation of the left atrium through the atrial septum, via the femoral vein, to drain the atrium and provide a means for temporary (less than six hours) left ventricular bypass [percutaneous transseptal ventricular assist (PTVA)]. It is a semi-rigid device (also known as a transseptal catheter) which may have a curved distal tip to better conform to the anatomy. Once in situ it is connected to an extracorporeal blood pump which returns blood to the patient. Disposable device dedicated to catheter introduction/function (e.g., obturator, dilator) may be included. This is a single-use device.	No	Active
34893	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial	A semi-rigid or rigid tube intended to be surgically inserted into an artery to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814112020722	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]