ESOTEST PROBE

Basic Information

• Brand Name: ESOTEST PROBE
• Primary DI: 08054242441925
• Version / Model: 26155S/US
• Catalog Number: 26155S/US
• Company Name: FIAB SPA
• Labeler DUNS: 439770017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-06
• Public Version: 1
• Public Version Date: 2019-12-16
• Public Version Status: New
• Public Device Record Key: 84cc7cb6-5ba6-4c32-9bc3-dea0364305b1

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46985	Oesophageal temperature monitor probe	A sterile device inserted into the oesophagus and intended to be used to transmit oesophageal tissue temperature information to a connected oesophageal temperature monitor during left atrial cardiac ablation, to help prevent atrial-oesophageal fistula formation. It is typically constructed of flexible materials (e.g., polymers) and has a metal conducting core; it has multiple sensors at the distal end and a connector at the proximal end. It may have electrodes that are used for temporary transoesophageal stimulation if connected to a cardiac stimulator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18054242441922	GS1		1	In Commercial Distribution
Primary	08054242441925	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123361	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius