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Esophageal/Rectal Temperature Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21076A
Identity
- Trade Name
- Esophageal/Rectal Temperature Probe 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 10Fr; probe length = 10' (3.1m); wgt = 1 lb (454g) FDA UDI
- Model / Reference
- 21076A EUDAMEDEsophageal/Rectal Temperature Probe FDA UDI
- Description
- Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size 10Fr; probe length = 10' (3.1m); wgt = 1 lb (454g) FDA UDI
Identifiers
- Catalog Number
- 21076A FDA UDI
- Primary DI / UDI-DI
- 00884838001008 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838001008 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER 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
- 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Esophageal/Rectal Temperature Probe 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-00884838001008 | 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 6ec67d07-1c57-4164-9bea-391bd39899b6 61 fields · synced Aug 3, 2026
- FDA UDI 53627c53-de76-4782-8f80-ef98cbeac973 37 fields · synced May 27, 2026