Identity
- Trade Name
- MEAS 4400 Series Temperature Probe EUDAMEDFDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- MEAS 4400 Series Temperature Probe EUDAMEDFoley Catheter Temperature Probe, 16 FR FDA UDI
- Model / Reference
- 861556 EUDAMED4466 FDA UDI
- Description
- Foley Catheter Temperature Probe, 16 FR FDA UDI
Identifiers
- Catalog Number
- 861556 FDA UDI
- Primary DI / UDI-DI
- D-H297446607X EUDAMEDH29744660 FDA UDI
- Basic UDI-DI
- B-H297446607X EUDAMED
- 510(k) Number
- K921561 FDA UDI
- FDA Product Code
- EZL FDA UDI
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMED
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- 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
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 16 French FDA UDI
MEAS 4400 Series Temperature Probe by Measurement Specialties, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-H297446607X | Class IIb | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Measurement Specialties Inc.
- EUDAMED SRN
- US-MF-000006309
- Authorised Representative
- MEAS Ireland IE-AR-000005162
Sources (2)
- EUDAMED 8f6cebb6-1d9f-476e-abcb-1e1a07a9dac9 61 fields · synced Jul 28, 2026
- FDA UDI 03966035-5107-4e6a-a993-fd0f34736fab 38 fields · synced May 30, 2026