Home GUDID 00810003380005 OPTIMIZER®
Primary DI 00810003380005
Brand OPTIMIZER®
Company Impulse Dynamics (usa) Inc.
Model CCM X10
Catalog number 10-B411-3-US
Device description OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart FailureSystem consists of:(1) OPTIMIZER Smart Implantable Pulse Generator (IPG)(1) Allen #2 torque wrench(1) Port Plug
Published 2019-04-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name QFV Implantable Pulse Generator
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QFV Implantable Pulse Generator Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810003380005 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810003380005 00810003380005 810003380005 0810003380005
GMDN Terms# Term, Definition table Term Definition Cardiac contractility modulation system pulse generator A hermetically-sealed, battery-powered device implanted beneath the skin to produce electrical signals delivered to the heart via implantable cardiac pacing leads during the ventricular absolute refractory period (ARP) to enhance the strength of the heart [cardiac contractility modulation (CCM)], typically as treatment for heart failure. The device is programmed by and transmits cardiac diagnostic data to an external programmer telemetrically.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 32 Degrees Fahrenheit 104 Degrees Fahrenheit
Regulatory Flags# DUNS number 878519342 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810003380135 Vesta Vesta Charger System (For OPTIMIZER Lite) 10-F302-3-XX 2024-02-26 00810003380074 Guardio Guardio Charger System 10-F311-3-XX 2023-03-27 00810003380081 Vesta Vesta Charger System 10-F301-3-XX 2022-04-29 00810003380043 OPTIMIZER™ Mini Charger System 10-F202-3-XX 2020-12-28 00810003380029 OPTIMIZER® Mini Charger System 10-F202-3-US 2019-04-12 00810003380142 OPTIMIZER Lite 10-B502-3-XX 2024-02-26 00810003380067 Intelio Intelio Portable Programmer Unit 10-A701-3-XX 2022-04-29 00810003380098 OPTIMIZER Smart Mini 10-B501-3-XX 2022-04-29 00810003380050 OPTIMIZER™ CCM X10 10-B411-3-XX 2020-12-28 00810003380012 OMNI™ II Programmer System (with OMNI Smart Software) 10-A604-3-US 2019-04-12
Other Devices Sharing Product Codes# 
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