FIAB SPA

Address:Via Costoli, 4,Vicchio Firenze,IT

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Device Description : The patient cable, F5417/US is the component of ESOTEST MULTI which connects the 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 Class : 2

Duns Number: 439770017

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

- Catalog Number : F9010SSC-6

Device Description : Reusable peripheral electrodes for ECG, 31.5x22mm dimensions, have features that Reusable peripheral electrodes for ECG, 31.5x22mm dimensions, have features that make them absolutely reliable during signal recording with all different ECG recorders on the market. The metallic part is silver coated (Ag/AgCl) allowing a safe and clear signal transmission. F9010SSC-6 thanks to screw and snap connections, can be tapped to all ECG recorders and monitors both with plug and snap. To be used with fasten belts.The product is Latex-free and Nickel-free.

Device Class :

Duns Number: 439770017

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 6

- Catalog Number : A113

Device Description : FIAB reusable praecordial suction chest electrodes for ECG, ball diameter Ø 33mm FIAB reusable praecordial suction chest electrodes for ECG, ball diameter Ø 33mm and rubber ring diameter Ø 30mm. A113 model has features that make it absolutely reliable during signal recording with all different ECG devices on the market. The metallic part is silver coated (Ag/AgCl) allowing a safe and clear signal transmission. The rings are made of rubber to improve patient’s comfort. FIAB suction chest electrodes thanks to screw and clip connections, can be tapped to all ECG devices and monitors with patient cables which have plug or snap connections. The product is latex-free and without Nickel

Device Class :

Duns Number: 439770017

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 6

- Catalog Number : F7817TPM70/30/US

Device Description : The ESOTEST MULTI Adapter Cable is an accessory for the ESOTEST MULTI system th The ESOTEST MULTI Adapter Cable is an accessory for the ESOTEST MULTI system that can be inserted in a dedicated socket on the handle of the ESOTEST MULTI Patient Cable for connecting the conductive terminals of ESOTEST MULTI Probe to a mapping system.At one end, the adapter cable is equipped with a custom plug compatible with the dedicated port in the patient cable. The other end of the cable contains seven single pole polyurethane cables, each one ending in a 2mm touch-proof plug compatible with the input ports of a mapping system.

Device Class : 2

Duns Number: 439770017

Premarket Exempt : No

Product Code : IKD

Prescription Use : Yes

Device Count : 1

- Catalog Number : ST-PROBE-5

Device Description : ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm) and a total length of 83 cm (usable length 75 cm) that is used for monitoring the internal temperature of the esophagus. The probe is equipped with 5 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature.

Device Class : 2

Duns Number: 439770017

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

- Catalog Number : ST-PROBE-7

Device Description : ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm) and a total length of 83 cm (usable length 75 cm) that is used for monitoring the internal temperature of the esophagus. The probe is equipped with 7 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature.

Device Class : 2

Duns Number: 439770017

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

- Catalog Number : ST-MONITOR

Device Description : ST-MONITOR is a device for monitoring of esophageal temperature on three differ ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temperature threshold alarm value between 36°C and 41°C.ST-MONITOR is equipped with three high precision thermometers to be connected, through an appropriate cable and connector, to the ST-PROBE. Using this device it is possible to follow, in immediate and precise way, the rise of the temperature inside the esophagous. The incorporated alarm system allows to the operator to set an adequate threshold temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm, the temperature and alarm signals can be sent to an external display and recording system through output signal connector.Sensitherm Multi System is intended for continue esophageal temperature monitoring and it consists of 3 components: ST-MONITOR, Patient Cable (ST-PTCBL model number) and Probe (ST-PROBE model number).

Device Class : 2

Duns Number: 439770017

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

- Catalog Number : ST-ADPT-30

Device Description : The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system th The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can be inserted in a dedicated socket on the handle of the ST-PTCBL patient cable for connecting the conductive terminals of ST -Probe to a mapping system.At one end, the adapter cable is equipped with a custom plug compatible with the dedicated port in the patient cable. The other end of the cable contains seven single pole polyurethane cables, each one ending in a 2mm touch-proof plug compatible with the input ports of a mapping system.

Device Class : 2

Duns Number: 439770017

Premarket Exempt : No

Product Code : IKD

Prescription Use : Yes

Device Count : 1

- Catalog Number : ST-PTCBL

Device Description : The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which co 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 Class : 2

Duns Number: 439770017

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

- Catalog Number : F9053/41

Device Description : Disposable ECG monitoring electrodes have features that make them abs Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9053/41 model are round-shaped electrodes, Ø 41mm, equipped with 35 cm long wire and 4mm socket, pre-gelled and they can be easily connected to the ECG monitor, avoiding pressure on the skin. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids.

Device Class :

Duns Number: 439770017

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 150