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E/R Temp Probe 12 FR Reuse Autoclavable
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989803203561
Identity
- Trade Name
- E/R Temp Probe 12 FR Reuse Autoclavable EUDAMEDTemperature Probes FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- Temperature Probes, Reusable EUDAMEDEsophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size = 12 Fr; probe length = 10' (3.1m); weight = 144g FDA UDI
- Model / Reference
- 989803203561 EUDAMEDE/R Temp Probe 12 FR Reuse Autoclavable FDA UDI
- Description
- Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size = 12 Fr; probe length = 10' (3.1m); weight = 144g FDA UDI
Identifiers
- Catalog Number
- 989803203561 FDA UDI
- Primary DI / UDI-DI
- 00884838089655 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838089655 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class IIa 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
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
E/R Temp Probe 12 FR Reuse Autoclavable by 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-00884838089655 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 05d6bf68-85af-4c97-98b9-efc0f4f6b9ca 61 fields · synced Jun 19, 2026
- FDA UDI 9136675a-db8e-497b-80bf-17a766b07a08 35 fields · synced May 30, 2026