THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP

Basic Information

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• Primary DI: 00813024010630
• Version / Model: 103696
• Catalog Number: 103696
• Company Name: Thoratec Corporation
• Labeler DUNS: 070156955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 6
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 64cd8c19-bab2-4e11-8d06-4ccb7e8b240e

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: 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
DSQ	Ventricular (Assisst) 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	00813024010630	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius