Intelio 10-A701-3-XX

GUDID 00810003380067

Intelio Programmer System consists of: (1) Intelio Programming Interface (1) Getac RX10 Tablet (1) Getac RX10 Charger (1) Intelio Programming Interface - Back Lid (1) Intelio Programming Wand (1) Legacy Programming Wand (1) Guardio/Vesta Update Cable (1) ECG cable, 3 Leads Snap (1) Manual insert

Impulse Dynamics (usa) Inc.

Cardiac contractility modulation system programmer
Primary Device ID00810003380067
NIH Device Record Key4f2858fc-0af3-4de4-8e68-abdcbe50f9cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntelio
Version Model NumberIntelio Portable Programmer Unit
Catalog Number10-A701-3-XX
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com
Phone8453592389
Emailcontact.us@impulse-dynamics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810003380067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFVImplantable Pulse Generator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

Devices Manufactured by Impulse Dynamics (usa) Inc.

00810003380135 - Vesta2024-03-05 Vesta Charger System (For OPTIMIZER Lite) consists of: (1) Vesta Charger (1) Battery Charger (1) EU Plug Adapter (1) US Plug Ada
00810003380142 - OPTIMIZER2024-03-05 OPTIMIZER Lite Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Lite Implantable
00810003380074 - Guardio2023-04-04 Guardio Charger System consists of: (1) Guardio Charger (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Manual I
00810003380067 - Intelio2022-05-09Intelio Programmer System consists of: (1) Intelio Programming Interface (1) Getac RX10 Tablet (1) Getac RX10 Charger (1) Intelio Programming Interface - Back Lid (1) Intelio Programming Wand (1) Legacy Programming Wand (1) Guardio/Vesta Update Cable (1) ECG cable, 3 Leads Snap (1) Manual insert
00810003380067 - Intelio2022-05-09 Intelio Programmer System consists of: (1) Intelio Programming Interface (1) Getac RX10 Tablet (1) Getac RX10 Charger (1) Inteli
00810003380081 - Vesta2022-05-09 Vesta Charger System consists of: (1) Vesta Charger (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Manual inser
00810003380098 - OPTIMIZER2022-05-09 OPTIMIZER Smart Mini Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Mini
00810003380043 - OPTIMIZER™2021-01-05 OPTIMIZER Mini Charger System consists of: (1) OPTIMIZER Mini Charger (with attached charging wand) (1) Battery Charger (1) EU P
00810003380050 - OPTIMIZER™2021-01-05 OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantab

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