FDA UDI
In Commercial Distribution
🇺🇸 United States
SENSITHERM MULTI
DI: 08058480754700
·
Model: ST-PTCBL
·
FIAB SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SENSITHERM MULTI
- Primary DI
- 08058480754700
- Version / Model
- ST-PTCBL
- Catalog Number
- ST-PTCBL
- Company Name
- FIAB SPA
- Labeler DUNS
- 439770017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-04
- Public Version
- 1
- Public Version Date
- 2022-02-14
- Public Version Status
- New
- Public Device Record Key
- 1cc43fa3-65f6-4c16-bd27-ee5e516fd31b
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46983 | Oesophageal temperature monitor | An electronic device used to monitor the temperature of the oesophagus during surgical ablation of the wall of the left atrium. It typically measures the oesophageal temperature at several adjacent levels, and displays these temperature values simultaneously to help the surgeon avoid the application of heat high enough to form atrial-oesophageal fistulas. A dedicated probe is inserted into the oesophagus and is connected to the monitor. An acoustic alarm may be included to indicate oesophageal temperatures have exceeded pre-set limits. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058480754700 | GS1 |
Customer Contacts
- Phone
- +39 0558497943
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192210 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity