ESOTEST ULTRA 30112

GUDID 08054242446364

ESOTEST 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. ESOTEST Monitor is equipped with three high precision thermometers to be connected, through an appropriate cable and connector, to the ESOTEST 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. ESOTEST System is intended for continue esophageal temperature monitoring and it consists of 3 components: monitor (30112 model numeber ), interconnect cable(F5406/ULTRA model number) and probe (26155S/US model number).

FIAB SPA

Oesophageal temperature monitor
Primary Device ID08054242446364
NIH Device Record Key3518840c-ad7c-4944-99ab-45bd2f34f106
Commercial Distribution StatusIn Commercial Distribution
Brand NameESOTEST ULTRA
Version Model Number30112
Catalog Number30112
Company DUNS439770017
Company NameFIAB SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39 0558497943
Emailquality@fiab.it

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108054242446364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-16
Device Publish Date2019-12-06

Devices Manufactured by FIAB SPA

08033695726360 - NA2024-09-24 ECG patient cables USA version
08033003264676 - NA2024-03-27 Reusable ECG patient cables
08033695726414 - NA2023-10-17 ECG patient cables USA version
08058480757985 - NA2023-07-28 ECG patient cables USA version
38033695726514 - F3001ECG2023-02-24 Disposable solid gel tab electrode for ECG
18058480753984 - SENSITHERM MULTI2022-02-14 ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm)
18058480753991 - SENSITHERM MULTI2022-02-14 ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm
08058480754021 - SENSITHERM MULITI 2022-02-14 ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temper

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.