ESOTEST ULTRA

Primary DI
08054242446364
Brand
ESOTEST ULTRA
Company
FIAB SPA
Model
30112
Catalog number
30112
Device description
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).
Published
2019-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123361000ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEMFiab Spa2013-02-27FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054242446364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054242446364080542424463648054242446364

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal temperature monitorAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39 0558497943quality@fiab.it

Regulatory Flags#

DUNS number
439770017
Device count
1
Serial number
true

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