Thoratec® HeartMate 3™

Basic Information

• Brand Name: Thoratec® HeartMate 3™
• Primary DI: 05415067031105
• Version / Model: 106531LF2
• Catalog Number: 106531LF2
• Company Name: Thoratec Corporation
• Labeler DUNS: 070156955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-13
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 43e685c8-fc42-448f-9c4b-de5306bf8954

Device Description

System Controller Low Flow 2.0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSQ	Ventricular (assist) bypass	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
37315	Implantable ventricular circulatory assist system control unit	An electrically-powered external component of an implantable ventricular circulatory assist system intended to supply power to the implanted system pump via a percutaneous lead (not included). It is typically a belt worn device used as a bridge to transplantation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067031105	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160054	016

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius