ESOTEST INTERCONNECT CABLE F5406/ULTRA

GUDID 08054242448061

ESOTEST ULTRA interconnect cable is intended to connect Monitor (ESOTEST ULTRA 30112 model number) to probe (ESOTEST PROBE 26155S/US model number). ESOTEST System is intended for continue esophageal temperature monitoring and it consists of 3 components: monitor, interconnect cable and probe.

FIAB SPA

Electrical-only medical device connection cable, reusable

• Primary Device ID: 08054242448061
• NIH Device Record Key: f89321c1-68c3-40d3-a1f2-607ea0b56271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESOTEST INTERCONNECT CABLE
• Version Model Number: F5406/ULTRA
• Catalog Number: F5406/ULTRA
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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 Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054242448061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123361

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-09
• Device Publish Date: 2019-12-06

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• 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)
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