OMNI™ II 10-A604-3-US

GUDID 00810003380012

OMNI™ II Programmer System (with OMNI Smart Software). System consists of: (1) OMNI II Programmer (with OMNI Smart Software) (1) OMNI II Programmer Tablet PC installed with OMNI Smart Programmer Software (1) OMNI II Programmer Interface Box (1) OMNI II Programmer Interface Box Cable (1) Medical-grade Ethernet isolator with Ethernet patch cable (1) OMNI II Programmer Wand (1) OMNI II Programmer Wand Extension Cable (1) USB to Serial Adapter Assembly (1) Single-lead (3-wire) ECG cable (1) Medical-grade Power Supply (1) Medical-grade Power Cord (1) Bluetooth printer with AC Adapter (2) Bluetooth printer paper rolls

IMPULSE DYNAMICS (USA) INC.

Cardiac contractility modulation system programmer

• Primary Device ID: 00810003380012
• NIH Device Record Key: c3d82dba-e3c9-4f38-a322-14725ced1b99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI™ II
• Version Model Number: Programmer System (with OMNI Smart Software)
• Catalog Number: 10-A604-3-US
• 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: false
• 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 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810003380012 [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: 2019-04-22
• Device Publish Date: 2019-04-12

Devices Manufactured by IMPULSE DYNAMICS (USA) INC.

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