ESOTEST ULTRA - ESOTEST Monitor is a device for monitoring of - FIAB SPA

Duns Number:439770017

Device Description: ESOTEST Monitor is a device for monitoring of esophageal temperature on three different po 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).

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

30112

Brand Name

ESOTEST ULTRA

Version/Model Number

30112

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

K123361

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

3518840c-ad7c-4944-99ab-45bd2f34f106

Public Version Date

December 16, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2019

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