ESOTEST MULTI PROBE 2615358H/US

GUDID 18054953343874

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 5 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature.

FIAB SPA

Oesophageal temperature monitor probe

• Primary Device ID: 18054953343874
• NIH Device Record Key: 2e6a267f-d871-49d1-908c-1524bffff7e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESOTEST MULTI PROBE
• Version Model Number: 2615358H/US
• Catalog Number: 2615358H/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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054953343877 [Primary]
GS1	18054953343874 [Package]; Contains: 08054953343877; Package: [1 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-12
• Device Publish Date: 2019-12-04

On-Brand Devices [ESOTEST MULTI PROBE ]

• 18054953343881: ESOTEST MULTI Probe is an esophageal lead made of an external isolating cover in medical polyure
• 18054953343874: ESOTEST MULTI Probe is an esophageal lead made of an external isolating cover in medical polyure