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Esophageal/Rectal Temperature Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989803100881Model Temperature Probes, Reusable
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 = 15 Fr; probe length = 10' (3.1m); wgt = l lb (454g) FDA UDI
- Model / Reference
- Temperature Probes, Reusable EUDAMED989803100881 EUDAMEDEsophageal/Rectal Temperature Probe FDA UDI
- Description
- Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size = 15 Fr; probe length = 10' (3.1m); wgt = l lb (454g) FDA UDI
Identifiers
- Catalog Number
- 21075A FDA UDI
- Primary DI / UDI-DI
- 00884838000995 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838000995 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
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
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-00884838000995 | 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 e13328a2-f8f6-4add-acb2-b126fa0b60d5 61 fields · synced Jul 16, 2026
- FDA UDI 35019b6f-a09f-40fd-9878-7f7dcb21cd49 37 fields · synced May 30, 2026