ESOTEST MULTI PROBE

Basic Information

• Brand Name: ESOTEST MULTI PROBE
• Primary DI: 08054953343884
• Version / Model: 2617376H/US
• Company Name: FIAB SPA
• Labeler DUNS: 439770017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-03
• Public Version: 1
• Public Version Date: 2019-12-11
• Public Version Status: New
• Public Device Record Key: f9531383-4dfe-4c40-b290-7fe98a3808c3

Device Description

ESOTEST MULTI Probe is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm) and a total length of 83 cm (usable length 75 cm) that is used for monitoring the internal temperature of the esophagus. The probe is equipped with 7 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature.

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: MR Unsafe
• 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	18054953343881	GS1		1	In Commercial Distribution
Primary	08054953343884	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192210	000

Storage Conditions

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