Vesta 10-F301-3-XX

GUDID 00810003380081

Vesta Charger System consists of: (1) Vesta 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: 00810003380081
• NIH Device Record Key: ceda5d50-cb1a-49a1-aee9-272045eac5ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vesta
• Version Model Number: Vesta Charger System
• Catalog Number: 10-F301-3-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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810003380081 [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: 2022-05-09
• Device Publish Date: 2022-04-29

On-Brand Devices [Vesta]

• 00810003380081: Vesta Charger System consists of: (1) Vesta Charger (1) Battery Charger (1) EU Plug Adapter (1)
• 00810003380135: Vesta Charger System (For OPTIMIZER Lite) consists of: (1) Vesta Charger (1) Battery Charger (1)