SENSITHERM MULTI ST-PTCBL

GUDID 08058480754700

The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which connects the main unit to the disposable temperature probe ST-PROBE. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make SENSITHERM MULTI System immune to the effects of a defibrillator discharge and other EMC disturbances. An contact custom socket on one side of the handle allows the user to connect the ST-PTCBL to a mapping system using the cable ST-ADPT-30.

FIAB SPA

Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor Oesophageal temperature monitor

• Primary Device ID: 08058480754700
• NIH Device Record Key: 1cc43fa3-65f6-4c16-bd27-ee5e516fd31b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENSITHERM MULTI
• Version Model Number: ST-PTCBL
• Catalog Number: ST-PTCBL
• 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: true
• 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
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058480754700 [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: 2022-02-14
• Device Publish Date: 2022-02-04

On-Brand Devices [SENSITHERM MULTI]

• 08058480754700: The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which connects the main
• 08058480754618: The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can be ins
• 18058480753991: ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane wi
• 18058480753984: ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical polyurethane wit