INTELLAGEN™ RF Generator Kit M004GEN100204010

GUDID 04260166374070

Stockert GmbH

Cardiac radio-frequency ablation system generator

• Primary Device ID: 04260166374070
• NIH Device Record Key: f46fe87d-5cff-4fea-abf9-d9ce508fd433
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTELLAGEN™ RF Generator Kit
• Version Model Number: 20401
• Catalog Number: M004GEN100204010
• Company DUNS: 327536314
• Company Name: Stockert GmbH
• 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: true
• 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: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com
• Phone: +1-888-272-1001
• Email: CETechSupportUSA@bsci.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry; Fragile, handle with care

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260166374070 [Primary]

FDA Product Code

• LPB: Cardiac Ablation Percutaneous Catheter

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: 2024-09-09
• Device Publish Date: 2024-09-01

Devices Manufactured by Stockert GmbH

• 04260166373066 - INTELLAGEN™ Foot Pedal: 2024-09-09
• 04260166373080 - INTELLAGEN™ Grounding Cable (3m): 2024-09-09
• 04260166373097 - INTELLAGEN™ ECG Connection Cable (3m): 2024-09-09
• 04260166373103 - INTELLAGEN™ Serial Communication Cable (5m): 2024-09-09
• 04260166373110 - INTELLAGEN™ Serial Communication Cable (15m): 2024-09-09
• 04260166373127 - INTELLAGEN™ Remote Control Connection Cable (25m): 2024-09-09
• 04260166373134 - INTELLAGEN™ Irrigation Pump Connection Cable (5m): 2024-09-09
• 04260166373158 - INTELLAGEN™ Catheter Adapter Cable (0.3m): 2024-09-09