ESOTEST MULTI PATIENT CABLE
Basic Information
- Brand Name
- ESOTEST MULTI PATIENT CABLE
- Primary DI
- 08054953344010
- Version / Model
- F5417/US
- Catalog Number
- F5417/US
- Company Name
- FIAB SPA
- Labeler DUNS
- 439770017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-06
- Public Version
- 1
- Public Version Date
- 2019-12-16
- Public Version Status
- New
- Public Device Record Key
- 883d2168-a22d-483d-ac6f-22d648c041aa
Device Description
The patient cable, F5417/US is the component of ESOTEST MULTI which connects the main unit to the disposable temperature probe ESOTEST MULTI Probe. The F5417/US is supplied with the 30115 ESOTEST MULTI MONITOR. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make ESOTEST MULTI immune to the effects of a defibrillator discharge and other EMC disturbances. An 18 contact custom socket on one side of the handle allows the user to connect the ESOTEST MULTI to a mapping system using the ESOTEST MULTI Adapter Cable. The F5417/US is supplied with the ESOTEST MULTI MONITOR 30115. The ESOTEST MULTI Patient Cable (F5417/US model number) is supplied togheter with the ESOTEST MULTI MONITOR (30115 model number) for the use of the ESOTEST Multi probe ( 2617376H/US and 2615358H/US model numbers).
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
- No
- 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 | 08054953344010 | 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