SENSITHERM MULITI - ST-MONITOR is a device for monitoring of - FIAB SPA

Duns Number:439770017

Device Description: ST-MONITOR is a device for monitoring of esophageal temperature on three different points 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).

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More Product Details

Catalog Number

ST-MONITOR

Brand Name

SENSITHERM MULITI

Version/Model Number

ST-MONITOR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192210

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

21d244fb-9c1e-46e9-9beb-73ae8d7f246e

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FIAB SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 42