Model 3145 391500

GUDID 04035479143190

BIOTRONIK SE & Co. KG

Implantable pacemaker analyser, intraoperative

• Primary Device ID: 04035479143190
• NIH Device Record Key: ea94c610-74c7-48ea-adfb-94a946beb7c8
• Commercial Distribution Discontinuation: 2020-10-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Model 3145
• Version Model Number: Refurbishment II
• Catalog Number: 391500
• Company DUNS: 315620229
• Company Name: BIOTRONIK SE & Co. KG
• 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(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479143190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950037

FDA Product Code

• OVJ: Pulse generator, external pacemaker, dual-chamber

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-19
• Device Publish Date: 2014-08-21

On-Brand Devices [Model 3145]

• 04035479143190: Refurbishment II
• 04035479143183: Refurbishment I
• 04035479143176: 369041