Identity
- Trade Name
- OMNI™ II FDA UDI
- Generic Name
- Cardiac contractility modulation system programmer FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- Programmer System (with OMNI Smart Software) FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- 10-A604-3-US FDA UDI
- Primary DI / UDI-DI
- 00810003380012 FDA UDI
- PMA Number
- P180036 FDA UDI
- FDA Product Code
- QFV FDA UDI
- GMDN Term
- Cardiac contractility modulation system programmer FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac contractility modulation system programmer
Omni™ Ii by Impulse Dynamics (usa) Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Impulse Dynamics (usa) Inc.
Sources (1)
- FDA UDI c3d82dba-e3c9-4f38-a322-14725ced1b99 37 fields · synced May 30, 2026