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).
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
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
FLL
Product Code Name
Thermometer, Electronic, Clinical
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 42 |