CentriMag™

Basic Information

• Brand Name: CentriMag™
• Primary DI: 07640135140566
• Version / Model: 201-52213
• Catalog Number: 201-52213
• Company Name: Thoratec Switzerland GmbH
• Labeler DUNS: 486066918
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-29
• Public Version: 1
• Public Version Date: 2022-04-06
• Public Version Status: New
• Public Device Record Key: 51e0e0cb-a3d0-4798-926b-21316564ff59

Device Description

USB Stick containing Mag Log Converter Software

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRI	ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS	Cardiovascular	870.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41578	Circulatory assist system application software	An application data program designed for use in, or together with a circulatory assist system, so that this may function according to its intended purpose. This software program may be permanently installed or exchanged as an upgrade.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640135140566	GS1

Customer Contacts

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