Identity
- Trade Name
- Intelio FDA UDI
- Generic Name
- Cardiac contractility modulation system programmer FDA UDI
- Device Name
- Intelio Programmer System consists of: (1) Intelio Programming Interface (1) Getac RX10 Tablet (1) Getac RX10 Charger (1) Intelio Programming Interface - Back Lid (1) Intelio Programming Wand (1) Legacy Programming Wand (1) Guardio/Vesta Update Cable (1) ECG cable, 3 Leads Snap (1) Manual insert FDA UDI
- Model / Reference
- Intelio Portable Programmer Unit FDA UDI
- Description
- Intelio Programmer System consists of: (1) Intelio Programming Interface (1) Getac RX10 Tablet (1) Getac RX10 Charger (1) Intelio Programming Interface - Back Lid (1) Intelio Programming Wand (1) Legacy Programming Wand (1) Guardio/Vesta Update Cable (1) ECG cable, 3 Leads Snap (1) Manual insert FDA UDI
Identifiers
- Catalog Number
- 10-A701-3-XX FDA UDI
- Primary DI / UDI-DI
- 00810003380067 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
Yes
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
Intelio by Impulse Dynamics (usa) Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac contractility modulation system programmer.
- OMNI™ II — Impulse Dynamics (usa) Inc. · Class III
Cleared under the same submission
P180036 also covers:
- Guardio — Impulse Dynamics (usa) Inc.
- OMNI™ II — Impulse Dynamics (usa) Inc.
- OPTIMIZER — Impulse Dynamics (usa) Inc.
- OPTIMIZER — Impulse Dynamics (usa) Inc.
- OPTIMIZER® — Impulse Dynamics (usa) Inc.
- OPTIMIZER® — Impulse Dynamics (usa) Inc.
- OPTIMIZER™ — Impulse Dynamics (usa) Inc.
- OPTIMIZER™ — Impulse Dynamics (usa) Inc.
- Vesta — Impulse Dynamics (usa) Inc.
- Vesta — Impulse Dynamics (usa) Inc.
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 4f2858fc-0af3-4de4-8e68-abdcbe50f9cf 37 fields · synced May 30, 2026