Identity
- Trade Name
- CARDIOTRONIC FDA UDI
- Generic Name
- Impedance cardiac output unit FDA UDI
- Device Name
- ICON Non-invasive Hemodynamic Cardiometer FDA UDI
- Model / Reference
- ICON FDA UDI
- Description
- ICON Non-invasive Hemodynamic Cardiometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260451441043 FDA UDI
- FDA Product Code
- DSB FDA UDI
- GMDN Term
- Impedance cardiac output unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 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
No
FDA UDI
Category: Impedance cardiac output unit
Cardiotronic by Osypka Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Osypka Medical, Inc.
Sources (1)
- FDA UDI 2163bc02-f1d9-4bf6-b390-4e7d5f46e2d6 35 fields · synced Jun 1, 2026