OPTIMIZER™ 10-F202-3-XX

GUDID 00810003380043

OPTIMIZER Mini Charger System consists of: (1) OPTIMIZER Mini Charger (with attached charging wand) (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Carrying Case

Impulse Dynamics (usa) Inc.

Implant battery charger

• Primary Device ID: 00810003380043
• NIH Device Record Key: 8015a874-9143-47af-8595-c6ebeedd5e63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIMIZER™
• Version Model Number: Mini Charger System
• Catalog Number: 10-F202-3-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: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• Email: contact.us@impulse-dynamics.com
• Phone: 845-359-2389
• 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
• 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	00810003380043 [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: 2021-01-05
• Device Publish Date: 2020-12-28

On-Brand Devices [OPTIMIZER™]

• 00810003380050: OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists o
• 00810003380043: OPTIMIZER Mini Charger System consists of: (1) OPTIMIZER Mini Charger (with attached charging wa