Identity
- Trade Name
- 103164 tCOM+ FDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- The Sentec patient monitor, model tCOM+, is a portable stand-alone patient monitor indicated for continuous, non-invasive patient monitoring of carbon dioxide partial pressure (PCO2), oxygen partial pressure (PO2), functional oxygen saturation (SpO2) and pulse rate (PR), using either: • a single, digital sensor (V-Sign™ Sensor 2) for PCO2, SpO2 and PR measurement, OR • a single, digital sensor (OxiVenT™ Sensor) for PCO2, PO2, SpO2 and PR measurement PO2 measurement with tCOM+ is only possible when used in combination with an OxiVenT™ Sensor. FDA UDI
- Model / Reference
- 103164 FDA UDI
- Description
- The Sentec patient monitor, model tCOM+, is a portable stand-alone patient monitor indicated for continuous, non-invasive patient monitoring of carbon dioxide partial pressure (PCO2), oxygen partial pressure (PO2), functional oxygen saturation (SpO2) and pulse rate (PR), using either: • a single, digital sensor (V-Sign™ Sensor 2) for PCO2, SpO2 and PR measurement, OR • a single, digital sensor (OxiVenT™ Sensor) for PCO2, PO2, SpO2 and PR measurement PO2 measurement with tCOM+ is only possible when used in combination with an OxiVenT™ Sensor. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640121880995 FDA UDI
- 510(k) Number
- K232516 FDA UDI
- FDA Product Code
- DPZ FDA UDIDQA FDA UDIKLK FDA UDILKD FDA UDILPP FDA UDI
- GMDN Term
- Transcutaneous blood gas monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2710 FDA UDI870.2700 FDA UDI868.2500 FDA UDI868.2480 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Pulse Co-oximeter probe, reusableTranscutaneous blood gas monitor sensorTranscutaneous blood gas monitoring system
103164 tCOM+ by Sentec, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Sentec, Inc.
Sources (1)
- FDA UDI 23fe4436-b174-4c82-8b2c-09af6c608531 35 fields · synced Jun 1, 2026