Esotest Multi Monitor

The ESOTEST MULTI Monitor tracks oesophageal temperature during clinical procedures involving heating or cooling. It receives data from a compatible ESOTEST MULTI probe with up to seven…

Registry build 21.09.26

The ESOTEST MULTI Monitor tracks oesophageal temperature during clinical procedures involving heating or cooling. It receives data from a compatible ESOTEST MULTI probe with up to seven independent temperature sensors.

The patient cable connects the probe to the monitor and converts thermocouple voltages into digital signals. The monitor presents temperature as numbers, coloured bars and scrolling plots. Users set upper and lower alarm thresholds to identify temperatures outside the selected limits.

Listed Item

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).

Recording and Alarms

Crossing either threshold triggers audible and visual alarms. Temperatures and alarm conditions can be stored internally for later review on the monitor or exported by USB storage for review on a computer.

115manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FLL
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Zhejiang Hongyu Medical Commodity Co., Ltd. Yiwu Zhejiang Contract manufacturer 36
Hochuen Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Jiangyin Sinbon Electronics Co Ltd Jiangyin Jiangsu Contract manufacturer 13
Tianjin Choice Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 12
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Famidoc Technology Co., Ltd. Dong Guan Guangdong Contract manufacturer 9
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9
Tasco Medical Industries Co., Ltd. Bao An District, Shenzhen Guangdong Contract manufacturer 6
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Betacera Inc. Suzhou Jiangsu Contract manufacturer 3

Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer

Record

Regulatory record for Esotest Multi Monitor
Listed by Fiab SPA, Italy
FDA product code FLL
Device type Continuous Measurement Thermometer
Device class Class 2
Regulation 21 CFR 880.2910
Establishment Manufacturer, Exporter
510(k) K192210
Record published 2019-12-06

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries serial number
Storage Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature 0 to 50 °C; Storage environment humidity 0 to 80 % RH

Catalogue Numbers

Catalogue numbers for Esotest Multi Monitor
Catalogue number Size Status
30115 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Unimed Unimed Medical Supplies Inc 434
Safety 1st Dorel Juvenile Group, Inc. 180
Welch Allyn, Inc. Welch Allyn, Inc. 66
Diagnostix™ American Diagnostic Corp. 61
DeRoyal Deroyal Industries, Inc. 58
Braun KAZ USA, Inc. 53
Exergen Temporal Scanner Exergen Corporation 50
Level 1 ICU Medical, Inc 48
Famidoc Famidoc Technology Co., Ltd. 47
Adtemp™ American Diagnostic Corp. 35
TempTraq Blue Spark Technologies, Inc. 35
Medline Medline Industries, Inc. 34

Showing 12 of 843. All products under Continuous Measurement Thermometer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K192210 2019-10-10
K180047 2018-11-08
K123361 2013-02-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer