ESOTEST MULTI MONITOR - The ESOTEST MULTI Monitor is a device for - FIAB SPA

Duns Number:439770017

Device Description: The ESOTEST MULTI Monitor is a device for measuring the esophageal temperature through the The ESOTEST MULTI Monitor is a device for measuring the esophageal temperature through the ESOTEST MULTI Probe, which contains up to seven independent thermal sensors. The cable which connects the main body of the monitor to the probe is called ESOTEST MULTI Patient Cable.With ESOTEST MULTI Monitor it is possible to follow, in an immediate and precise way, the evolution of the temperature inside the esophagus. When an alarm is triggered, the system generates sound and visual effects aimed at getting the attention of the operator. The measured temperatures and the alarm conditions (if any) can be stored in the internal memory of the monitor and examined at a later time on the monitor itself or on an external personal computer (after exporting the corresponding data to an USB mass storage device). The ESOTEST MULTI MONITOR (30115 model number) is supplied togheter with the ESOTEST MULTI Patient Cable (F5417/US model number) for the use of the ESOTEST Multi probe ( 2617376H/US and 2615358H/US model numbers).

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More Product Details

Catalog Number

30115

Brand Name

ESOTEST MULTI MONITOR

Version/Model Number

30115

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

b8ddfc6f-a8c0-4714-a9a6-fdc23e8eba75

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