ESOTEST PROBE 26155S/US

GUDID 18054242441922

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.

FIAB SPA

Oesophageal temperature monitor probe

• Primary Device ID: 18054242441922
• NIH Device Record Key: 84cc7cb6-5ba6-4c32-9bc3-dea0364305b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESOTEST PROBE
• Version Model Number: 26155S/US
• Catalog Number: 26155S/US
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054242441925 [Primary]
GS1	18054242441922 [Package]; Contains: 08054242441925; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123361

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

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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