Identity
- Trade Name
- Temperature Parameter Module EUDAMEDTemperature Module FDA UDI
- Generic Name
- Patient monitoring system module, temperature FDA UDI
- Device Name
- Temperature Module EUDAMEDTemperature Parameter Module for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The Temperature Module provides continuous body temperature readings at a variety of sites including skin, rectal, nasal, esophageal, arterial, and venous. FDA UDI
- Model / Reference
- 862291 EUDAMEDTemperature Parameter Module FDA UDI
- Description
- Temperature Parameter Module for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The Temperature Module provides continuous body temperature readings at a variety of sites including skin, rectal, nasal, esophageal, arterial, and venous. FDA UDI
Identifiers
- Catalog Number
- 862291 FDA UDI
- Primary DI / UDI-DI
- 00884838021082 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838021082 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, temperature FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Electrical-only medical device connection cable, reusable
Temperature Parameter Module by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838021082 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED a6fbb471-ae75-4ed4-9149-551b830c90d4 61 fields · synced Oct 6, 2026
- FDA UDI e8699f8e-d618-4345-8b6f-37cc287d15b2 36 fields · synced May 30, 2026