Plexa ProMRI DF-1 413997

GUDID 04035479150969

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead

• Primary Device ID: 04035479150969
• NIH Device Record Key: 54fc39c8-9db7-4028-9d6e-689b61c85b73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plexa ProMRI DF-1
• Version Model Number: S 65
• Catalog Number: 413997
• Company DUNS: 315620229
• Company Name: BIOTRONIK SE & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479150969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980023

FDA Product Code

• NVY: Permanent defibrillator electrodes

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-05
• Device Publish Date: 2018-03-01

On-Brand Devices [Plexa ProMRI DF-1]

• 04035479150983: SD 60/16
• 04035479150952: S 60
• 04035479150976: S 75
• 04035479150969: S 65