Identity
- Trade Name
- FlexTEMP II Sensor EUDAMEDExpression MR FlexTEMP II Sensor FDA UDI
- Generic Name
- Continuous electronic patient thermometer, battery-powered FDA UDI
- Device Name
- Reusable Temp Probe and Disp Jacket EUDAMEDTemperature sensor for Expression MRI patient monitors, capable of surface measurement or, with applied FlexTEMP Jacket, esophogeal/nasal/rectal body temperature. FDA UDI
- Model / Reference
- 989803194511 EUDAMEDFlexTEMP II Sensor FDA UDI
- Description
- Temperature sensor for Expression MRI patient monitors, capable of surface measurement or, with applied FlexTEMP Jacket, esophogeal/nasal/rectal body temperature. FDA UDI
Identifiers
- Catalog Number
- 989803194511 FDA UDI
- Primary DI / UDI-DI
- 00884838056077 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838056077 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Continuous electronic patient thermometer, battery-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 Safe FDA UDI
FlexTEMP II Sensor by Invivo, a division of Philips Medical Systems — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838056077 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 3455bb8d-28f0-41de-beac-25c16ba2fd18 61 fields · synced Jun 17, 2026
- FDA UDI e1ac5ac5-9f3a-4e5a-a742-7ec4830076bb 37 fields · synced May 30, 2026