Valleylab FX8 VLFX8GENZD

GUDID 10884521780408

FX Series Energy Platform

Covidien LP

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator

• Primary Device ID: 10884521780408
• NIH Device Record Key: c598685d-490c-4797-bccc-4d7a8e658c78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valleylab FX8
• Version Model Number: VLFX8GENZD
• Catalog Number: VLFX8GENZD
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• Serial Number: true
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *The system can be stored for up to 1 year without performance degradation upon use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521780408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181389

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

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: 2020-01-27
• Device Publish Date: 2020-01-17

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