Temperature Sensor Jacket
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Temperature Sensor Jacket EUDAMEDMR Patient Care Temperature Sensor Jacket FDA UDI
- Generic Name
- Electronic thermometer probe cover FDA UDI
- Device Name
- Reusable Temp Probe and Disp Jacket EUDAMEDDisposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the FlexTEMP Sensor while measuring Body temperature. This Sensor should also be used for surface temperature to reduce the occurrence of infection FDA UDI
- Model / Reference
- Reusable Temp Probe and Disp Jacket EUDAMED989803178181 EUDAMEDTemperature Sensor Jacket FDA UDI
- Description
- Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the FlexTEMP Sensor while measuring Body temperature. This Sensor should also be used for surface temperature to reduce the occurrence of infection FDA UDI
Identifiers
- Catalog Number
- 989803178181 FDA UDI
- Primary DI / UDI-DI
- 10884838129938 EUDAMED10884838111407 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1078ME EUDAMED
- Unit of Use DI
- 00884838129931 EUDAMED00884838111400 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Electronic thermometer probe cover FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
No
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
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General-purpose multi-parameter bedside monitor
Temperature Sensor Jacket by Philips Medizin Systeme Böblingen GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM1078ME | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (3)
- EUDAMED a82b62cf-7d50-472f-beb6-bfa7a85746a5 61 fields · synced Oct 6, 2026
- EUDAMED 327250d8-c3b8-4bc7-9cb7-c27eecac5503 61 fields · synced May 19, 2026
- FDA UDI 2483769f-957b-474e-8a5a-d3a4828b6b68 35 fields · synced May 30, 2026