VAPR 225021

GUDID 10886705009107

VAPR 3 Generator REUSABLE

DEPUY MITEK, LLC

Electrosurgical system generator

• Primary Device ID: 10886705009107
• NIH Device Record Key: c198ca9f-f21e-49ee-9b1b-24860873704d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VAPR
• Version Model Number: 225021
• Catalog Number: 225021
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• 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: 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Special Storage Condition, Specify: Between 0 and 0 *Waste from Electrical and Electronic Equipment
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705009107 [Primary]

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-04-04
• Device Publish Date: 2017-04-04

On-Brand Devices [VAPR]

• 10886705009077: VAPR Sterilization Tray
• 10886705009107: VAPR 3 Generator REUSABLE
• 10886705009381: VAPR LP Suction Electrode 4 mm x 160 mm
• 10886705009374: VAPR LD Suction Electrode 4 mm x 160 mm