Identity
- Trade Name
- Foley Catheter Temperature Probe EUDAMEDTemperature Probes FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- Temperature Probes, Single-use EUDAMEDFoley Catheter Temperature Probe Disposable; size = 18 Fr; probe length = 17" (43cm); sterile; minimum shelf life = 12 months; 1 cs = 10 probes; wgt = 1 lb (454g) FDA UDI
- Model / Reference
- 21097A EUDAMEDFoley Catheter Temperature Probe FDA UDI
- Description
- Foley Catheter Temperature Probe Disposable; size = 18 Fr; probe length = 17" (43cm); sterile; minimum shelf life = 12 months; 1 cs = 10 probes; wgt = 1 lb (454g) FDA UDI
Identifiers
- Catalog Number
- 21097A FDA UDI
- Primary DI / UDI-DI
- 20884838006922 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838006922 EUDAMED
- FDA Product Code
- EZL FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Foley Catheter 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-20884838006922 | 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 3ffa689a-08c7-44d3-916f-53058f79c3e3 61 fields · synced Sep 17, 2026
- FDA UDI 68e20a60-e698-4f06-a2d5-27721784dd5b 37 fields · synced May 29, 2026