ESOTEST MULTI PATIENT CABLE F5417/US

GUDID 08054953344010

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).

FIAB SPA

Oesophageal temperature monitor

• Primary Device ID: 08054953344010
• NIH Device Record Key: 883d2168-a22d-483d-ac6f-22d648c041aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESOTEST MULTI PATIENT CABLE
• Version Model Number: F5417/US
• Catalog Number: F5417/US
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39 0558497943
• Email: quality@fiab.it

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054953344010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192210

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-16
• Device Publish Date: 2019-12-06

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• 38033695726514 - F3001ECG: 2023-02-24 Disposable solid gel tab electrode for ECG
• 18058480753984 - SENSITHERM MULTI: 2022-02-14 ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm)
• 18058480753991 - SENSITHERM MULTI: 2022-02-14 ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm
• 08058480754021 - SENSITHERM MULITI: 2022-02-14 ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temper