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St-Ptcbl
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ST-PTCBLModel SENSITHERM MULTI - Patient cable
by FIAB S.p.A.
Identity
- Trade Name
- SENSITHERM MULTI FDA UDI
- Generic Name
- Oesophageal temperature monitor FDA UDI
- Device Name
- The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which connects the main unit to the disposable temperature probe ST-PROBE. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make SENSITHERM MULTI System immune to the effects of a defibrillator discharge and other EMC disturbances. An contact custom socket on one side of the handle allows the user to connect the ST-PTCBL to a mapping system using the cable ST-ADPT-30. FDA UDI
- Model / Reference
- SENSITHERM MULTI - Patient cable EUDAMEDST-PTCBL EUDAMEDFDA UDI
- Description
- The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which connects the main unit to the disposable temperature probe ST-PROBE. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make SENSITHERM MULTI System immune to the effects of a defibrillator discharge and other EMC disturbances. An contact custom socket on one side of the handle allows the user to connect the ST-PTCBL to a mapping system using the cable ST-ADPT-30. FDA UDI
Identifiers
- Catalog Number
- ST-PTCBL FDA UDI
- Primary DI / UDI-DI
- 08058480754700 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326103000006LD EUDAMED
- Direct Marketing DI
- 08058480754700 EUDAMED
- 510(k) Number
- K192210 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V030199 BODY TEMPERATURE MEASURING DEVICES - OTHER EUDAMED
- GMDN Term
- Oesophageal temperature monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Italy 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
No
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
St-Ptcbl by FIAB S.p.A. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803300326103000006LD | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (2)
- EUDAMED 1c5268d9-8ef1-4856-a3a0-eccbbbecaaaf 61 fields · synced Aug 1, 2026
- FDA UDI 1cc43fa3-65f6-4c16-bd27-ee5e516fd31b 37 fields · synced May 30, 2026