Identity
- Trade Name
- Model 3 FDA UDI
- Generic Name
- Electrocardiographic signal amplifier FDA UDI
- Device Name
- Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals; re-manufactured, (single unit package). FDA UDI
- Model / Reference
- Re-manufactured, single pack FDA UDI
- Description
- Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals; re-manufactured, (single unit package). FDA UDI
Identifiers
- Catalog Number
- 0104-9999 FDA UDI
- Primary DI / UDI-DI
- 10856233005193 FDA UDI
- PMA Number
- P860008 FDA UDI
- FDA Product Code
- LPA FDA UDI
- GMDN Term
- Electrocardiographic signal amplifier 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: Electrocardiographic signal amplifier
Model 3 by Cardio Command — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P860008 also covers:
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
- Cardio Command
Sources (1)
- FDA UDI 50ec0ccf-2339-4b22-b4db-fb2a09ad6fb2 37 fields · synced Jun 6, 2026