SENSITHERM MULITI

Primary DI
08058480754021
Brand
SENSITHERM MULITI
Company
FIAB SPA
Model
ST-MONITOR
Catalog number
ST-MONITOR
Device description
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).
Published
2022-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K192210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192210000ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa2019-10-10FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058480754021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058480754021080584807540218058480754021

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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18033695727166NAF7277F72772020-05-14
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