AccessGUDID - DEVICE: ESOTEST MULTI PATIENT CABLE (08054953344010)

GUDID

Device Identifier (DI) Information

Brand Name: ESOTEST MULTI PATIENT CABLE
Version or Model: F5417/US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F5417/US
Company Name: FIAB SPA

Primary DI Number: 08054953344010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439770017 *Terms of Use

Device Description: The patient cable, F5417/US is the component of ESOTEST MULTI which connects the main unit to the disposable temperature probe ESOTEST MULTI Probe. The F5417/US is supplied with the 30115 ESOTEST MULTI MONITOR. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make ESOTEST MULTI immune to the effects of a defibrillator discharge and other EMC disturbances. An 18 contact custom socket on one side of the handle allows the user to connect the ESOTEST MULTI to a mapping system using the ESOTEST MULTI Adapter Cable. The F5417/US is supplied with the ESOTEST MULTI MONITOR 30115. The ESOTEST MULTI Patient Cable (F5417/US model number) is supplied togheter with the ESOTEST MULTI MONITOR (30115 model number) for the use of the ESOTEST Multi probe ( 2617376H/US and 2615358H/US model numbers).

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":	No
For Single-Use:	No
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?
46983	Oesophageal temperature monitor	An electronic device used to monitor the temperature of the oesophagus during surgical ablation of the wall of the left atrium. It typically measures the oesophageal temperature at several adjacent levels, and displays these temperature values simultaneously to help the surgeon avoid the application of heat high enough to form atrial-oesophageal fistulas. A dedicated probe is inserted into the oesophagus and is connected to the monitor. An acoustic alarm may be included to indicate oesophageal temperatures have exceeded pre-set limits.	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: No
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 0 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 883d2168-a22d-483d-ac6f-22d648c041aa
Public Version Date: December 16, 2019
Public Version Number: 1
DI Record Publish Date: December 06, 2019