Guardio 10-F311-3-XX
GUDID 00810003380074
Guardio Charger System consists of: (1) Guardio Charger (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Manual Insert
Impulse Dynamics (usa) Inc.
Implant battery charger| Primary Device ID | 00810003380074 |
| NIH Device Record Key | 114126cb-3e30-4f1f-b103-49981745a889 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guardio |
| Version Model Number | Guardio Charger System |
| Catalog Number | 10-F311-3-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 |
Customer Support Contacts
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com | |
| Phone | 8453592389 |
| contact.us@impulse-dynamics.com |
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810003380074 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P180036
FDA Product Code
| QFV | Implantable Pulse Generator |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-04 |
| Device Publish Date | 2023-03-27 |
Devices Manufactured by Impulse Dynamics (usa) Inc.
| 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 | 2023-04-04Guardio Charger System consists of: (1) Guardio Charger (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Manual Insert |
| 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 | 2022-05-09 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 |
Trademark Results [Guardio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUARDIO 97654816 not registered Live/Pending |
Guardio Ltd. 2022-10-31 |
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