TandemHeart

Basic Information

• Brand Name: TandemHeart
• Primary DI: 00814112020388
• Version / Model: 5710-7217
• Company Name: CARDIACASSIST, INC.
• Labeler DUNS: 948683941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-18
• Public Version: 5
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: fb58a717-c8c1-405d-9f9d-db61430f0242

Device Description

TandemHeart blood pump kit with 72cm venous and 17Fr arterial cannulae

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: Labeling does not contain MRI Safety Information
• 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
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	870.4360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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
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
47733	Cardiopulmonary bypass cannula, femoral	A sterile, rigid or semi-rigid tube designed to be inserted into a femoral artery or vein during cardiopulmonary bypass procedures. It is typically a 9 to 24 Fr tube with an end hole (some may include side holes); it is short enough to keep the distal tip inside the femoral vessel. The tube is used in set-ups/systems intended to divert the patient's blood to and from external tubing and an arterial pump, bypassing the heart and lungs completely. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814112020388	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082425	000
K110493	000
K120543	000