FDA.reportPublic FDA data

OMNI™ II

Primary DI
00810003380012
Brand
OMNI™ II
Company
Impulse Dynamics (usa) Inc.
Model
Programmer System (with OMNI Smart Software)
Catalog number
10-A604-3-US
Device description
OMNI™ II Programmer System (with OMNI Smart Software). System consists of:(1) OMNI II Programmer (with OMNI Smart Software)(1) OMNI II Programmer Tablet PC installed with OMNI Smart Programmer Software(1) OMNI II Programmer Interface Box(1) OMNI II Programmer Interface Box Cable(1) Medical-grade Ethernet isolator with Ethernet patch cable(1) OMNI II Programmer Wand(1) OMNI II Programmer Wand Extension Cable(1) USB to Serial Adapter Assembly(1) Single-lead (3-wire) ECG cable(1) Medical-grade Power Supply(1) Medical-grade Power Cord(1) Bluetooth printer with AC Adapter(2) Bluetooth printer paper rolls
Published
2019-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFVImplantable Pulse Generator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFVImplantable Pulse GeneratorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180036000OPTIMIZER Smart SystemImpulse Dynamics (Usa), Inc.2019-03-21QFV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810003380012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810003380012008100033800128100033800120810003380012

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac contractility modulation system programmerA portable, battery-powered device used by healthcare personnel to telemetrically receive diagnostic data from and modify the cardiac contractility signal parameters of an implanted pulse generator of a cardiac contractility modulation (CCM) system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
845-359-2389contact.us@impulse-dynamics.com

Regulatory Flags#

DUNS number
878519342
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003380135VestaVesta Charger System (For OPTIMIZER Lite)10-F302-3-XX2024-02-26
00810003380074GuardioGuardio Charger System10-F311-3-XX2023-03-27
00810003380081VestaVesta Charger System10-F301-3-XX2022-04-29
00810003380043OPTIMIZER™Mini Charger System10-F202-3-XX2020-12-28
00810003380029OPTIMIZER®Mini Charger System10-F202-3-US2019-04-12
00810003380142OPTIMIZERLite10-B502-3-XX2024-02-26
00810003380067IntelioIntelio Portable Programmer Unit10-A701-3-XX2022-04-29
00810003380098OPTIMIZERSmart Mini10-B501-3-XX2022-04-29
00810003380050OPTIMIZER™CCM X1010-B411-3-XX2020-12-28
00810003380005OPTIMIZER®CCM X1010-B411-3-US2019-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003380135VestaImpulse Dynamics (usa) Inc.QFV2024-02-26
00810003380142OPTIMIZERImpulse Dynamics (usa) Inc.QFV2024-02-26
00810003380074GuardioImpulse Dynamics (usa) Inc.QFV2023-03-27
00810003380067IntelioImpulse Dynamics (usa) Inc.QFV2022-04-29
00810003380081VestaImpulse Dynamics (usa) Inc.QFV2022-04-29
00810003380098OPTIMIZERImpulse Dynamics (usa) Inc.QFV2022-04-29
00810003380043OPTIMIZER™Impulse Dynamics (usa) Inc.QFV2020-12-28
00810003380050OPTIMIZER™Impulse Dynamics (usa) Inc.QFV2020-12-28
00810003380005OPTIMIZER®Impulse Dynamics (usa) Inc.QFV2019-04-12
00810003380029OPTIMIZER®Impulse Dynamics (usa) Inc.QFV2019-04-12