OPTIMIZER® 10-B411-3-US

GUDID 00810003380005

OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug

IMPULSE DYNAMICS (USA) INC.

Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator Cardiac contractility modulation system pulse generator
Primary Device ID00810003380005
NIH Device Record Key2c78fead-0009-44a9-ae02-ae2b66459c27
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTIMIZER®
Version Model NumberCCM X10
Catalog Number10-B411-3-US
Company DUNS878519342
Company NameIMPULSE DYNAMICS (USA) INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810003380005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFVImplantable Pulse Generator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

On-Brand Devices [OPTIMIZER®]

00810003380029OPTIMIZER Mini Charger System consists of: (1) OPTIMIZER Mini Charger (with attached charging wa
00810003380005OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists o

Trademark Results [OPTIMIZER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTIMIZER
OPTIMIZER
98404259 not registered Live/Pending
SKS Industries, Inc.
2024-02-13
OPTIMIZER
OPTIMIZER
90510200 not registered Live/Pending
Enerco Group, Inc.
2021-02-04
OPTIMIZER
OPTIMIZER
90239421 not registered Live/Pending
Optimatics Pty Ltd
2020-10-07
OPTIMIZER
OPTIMIZER
88781257 not registered Live/Pending
Matthew Bulmer
2020-01-31
OPTIMIZER
OPTIMIZER
88352470 not registered Live/Pending
Conmed Corporation
2019-03-22
OPTIMIZER
OPTIMIZER
88048884 not registered Dead/Abandoned
Encapsulation Technologies, Inc.
2018-07-23
OPTIMIZER
OPTIMIZER
87750751 not registered Live/Pending
Global Marine Networks, LLC
2018-01-10
OPTIMIZER
OPTIMIZER
87191841 5204394 Live/Registered
Todd Williams
2016-10-03
OPTIMIZER
OPTIMIZER
87191841 5204394 Live/Registered
Cynthia Williams
2016-10-03
OPTIMIZER
OPTIMIZER
86717298 not registered Dead/Abandoned
FLUIDMASTER, INC.
2015-08-06
OPTIMIZER
OPTIMIZER
86392126 4723557 Live/Registered
SJB BRANDS, LLC
2014-09-11
OPTIMIZER
OPTIMIZER
86019691 4973519 Live/Registered
MINDRAY DS USA, INC.
2013-07-25

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