Identity
- Trade Name
- Capnography extension FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- Capnography Extension works together with the IntelliVue Multi-Measurement Module (MMS), the IntelliVue X2 Multi-Measurement Module and IntelliVue MP2 Patient Monitor. The base product provides CO2 waveform, inspired minimum (imCO2), endtidal CO2 (etCO2) and Airway Respiration Rate (awRR) of intubated and non-intubated adult, pediatric and neonatal patients varies care areas inside the hospital. Optional Invasive Pressure, Temperature Cardiac Output (C.O.) and Continuous C.O. PiCCO can be selected via C-options. FDA UDI
- Model / Reference
- 862187 FDA UDI
- Description
- Capnography Extension works together with the IntelliVue Multi-Measurement Module (MMS), the IntelliVue X2 Multi-Measurement Module and IntelliVue MP2 Patient Monitor. The base product provides CO2 waveform, inspired minimum (imCO2), endtidal CO2 (etCO2) and Airway Respiration Rate (awRR) of intubated and non-intubated adult, pediatric and neonatal patients varies care areas inside the hospital. Optional Invasive Pressure, Temperature Cardiac Output (C.O.) and Continuous C.O. PiCCO can be selected via C-options. FDA UDI
Identifiers
- Catalog Number
- 862187 FDA UDI
- Primary DI / UDI-DI
- 00884838021549 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
MR Unsafe FDA UDI
Category: Patient monitoring system module, multifunction
Capnography extension by Philips Medizin Systeme Böblingen GmbH — 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
- Philips Medizin Systeme Böblingen GmbH
Sources (1)
- FDA UDI d31461be-9878-4b43-83de-11680024f89f 36 fields · synced Jun 8, 2026