CENTRIMAG® Back-Up Console with Batteries

Basic Information

• Brand Name: CENTRIMAG® Back-Up Console with Batteries
• Primary DI: 07640135140863
• Version / Model: 102966
• Catalog Number: 102966
• Company Name: Thoratec Switzerland GmbH
• Labeler DUNS: 486066918
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 5
• Public Version Date: 2019-02-06
• Public Version Status: Update
• Public Device Record Key: 88d44f73-42e6-4b00-855a-9ca2705861aa

Device Description

Back-Up Console with Batteries

Device Characteristics

• Single Use: No
• 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: No
• 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
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	870.4380	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33663	Cardiopulmonary bypass system centrifugal pump backup drive unit	A mains electricity (AC-powered) device, with an internal battery, that substitutes as the drive unit for a cardiopulmonary bypass system centrifugal pump to circulate blood through the extracorporeal circuit in the event of the loss of mains electricity. It typically includes monitoring and alarm functions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640135140863	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -15 – 30 Degrees Celsius