ESOTEST MULTI MONITOR 30115

GUDID 08054953344003

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).

FIAB SPA

Oesophageal temperature monitor

• Primary Device ID: 08054953344003
• NIH Device Record Key: b8ddfc6f-a8c0-4714-a9a6-fdc23e8eba75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESOTEST MULTI MONITOR
• Version Model Number: 30115
• Catalog Number: 30115
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39 0558497943
• Email: quality@fiab.it

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054953344003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192210

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-16
• Device Publish Date: 2019-12-06

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• 18058480753984 - SENSITHERM MULTI: 2022-02-14 ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm)
• 18058480753991 - SENSITHERM MULTI: 2022-02-14 ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm
• 08058480754021 - SENSITHERM MULITI: 2022-02-14 ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temper
• 08058480754618 - SENSITHERM MULTI: 2022-02-14 The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can be inserted in a dedicated socket