ESOTEST PROBE - ESOTEST Probe is an esophageal lead made of an - FIAB SPA

Duns Number:439770017

Device Description: ESOTEST Probe is an esophageal lead made of an external isolating cover in medical polyure ESOTEST Probe is an esophageal lead made of an external isolating cover in medical polyurethane Ø 7 French (2,3mm), total length 95 cm (usable length 75 cm) that is used for monitoring the internal temperature of esophagus tube. It is equipped with 5 steel rounded electrodes, each of the three intermediate electrodes is connected to a thermocouple for independent detection of esophageal temperature. The distal and the proximal electrodes are connected to auxiliary outlets through which, in case of need, they can be connected to other (recording) devices providing the output as an electrical signal. The distal end has a rounded-off tip, made a-traumatic by a special silicone cover.ESOTEST Probe is equipped with a trapezoidal connector box (“yoke”) made of ABS plastic, its main purpose is connection of probe to the monitor for the continuous recording of temperature, connection is realized by 3 miniature sockets that are embedded in the box. ESOTEST System is intended for continue esophageal temperature monitoring and it consists of 3 components: Monitor (ESOTEST ULTRA 30112 model number) , Interconnect cable (F5406/ULTRA model number) and Probe.

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More Product Details

Catalog Number

26155S/US

Brand Name

ESOTEST PROBE

Version/Model Number

26155S/US

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"

Yes

For Single-Use

Yes

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,K123361

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

84cc7cb6-5ba6-4c32-9bc3-dea0364305b1

Public Version Date

December 16, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2019

Additional Identifiers

Package DI Number

18054242441922

Quantity per Package

1

Contains DI Package

08054242441925

Package Discontinue Date

-

Package Status

In Commercial Distribution

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