AccessGUDID - DEVICE: ESOTEST PROBE (08054242441925)

GUDID

Device Identifier (DI) Information

Brand Name: ESOTEST PROBE
Version or Model: 26155S/US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 26155S/US
Company Name: FIAB SPA

Primary DI Number: 08054242441925
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439770017 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123361	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 84cc7cb6-5ba6-4c32-9bc3-dea0364305b1
Public Version Date: December 16, 2019
Public Version Number: 1
DI Record Publish Date: December 06, 2019