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.

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• 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
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: contact.us@impulse-dynamics.com
• Phone: 8453592389
• Email: 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.

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• 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