| Primary Device ID | 00810003380067 |
| NIH Device Record Key | 4f2858fc-0af3-4de4-8e68-abdcbe50f9cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intelio |
| Version Model Number | Intelio Portable Programmer Unit |
| Catalog Number | 10-A701-3-XX |
| Company DUNS | 878519342 |
| Company Name | Impulse Dynamics (usa) Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 00810003380135 - Vesta | 2024-03-05 Vesta Charger System (For OPTIMIZER Lite) consists of:
(1) Vesta Charger
(1) Battery Charger
(1) EU Plug Adapter
(1) US Plug Ada |
| 00810003380142 - OPTIMIZER | 2024-03-05 OPTIMIZER Lite Implantable Pulse Generator for the Treatment of Heart Failure
System consists of:
(1) OPTIMIZER Lite Implantable |
| 00810003380074 - Guardio | 2023-04-04 Guardio Charger System consists of:
(1) Guardio Charger
(1) Battery Charger
(1) EU Plug Adapter
(1) US Plug Adapter
(1) Manual I |
| 00810003380067 - Intelio | 2022-05-09Intelio 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 - Intelio | 2022-05-09 Intelio Programmer System consists of:
(1) Intelio Programming Interface
(1) Getac RX10 Tablet
(1) Getac RX10 Charger
(1) Inteli |
| 00810003380081 - Vesta | 2022-05-09 Vesta Charger System consists of:
(1) Vesta Charger
(1) Battery Charger
(1) EU Plug Adapter
(1) US Plug Adapter
(1) Manual inser |
| 00810003380098 - OPTIMIZER | 2022-05-09 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 |