AccessGUDID - DEVICE: SENSITHERM MULTI (08058480753994)

GUDID

Device Identifier (DI) Information

Brand Name: SENSITHERM MULTI
Version or Model: ST-PROBE-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST-PROBE-7
Company Name: FIAB SPA

Primary DI Number: 08058480753994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439770017 *Terms of Use

Device Description: ST-PROBE-7 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

What MRI safety information does the labeling contain?	MR Unsafe
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 [?]
K192210	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 Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e69d4c9b-29e5-4e43-b47a-4ae442515d96
Public Version Date: February 14, 2022
Public Version Number: 1
DI Record Publish Date: February 04, 2022