Plexa ProMRI 402264

GUDID 04035479140007

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead

• Primary Device ID: 04035479140007
• NIH Device Record Key: 6b02313c-4051-4ae6-9f92-801891e5487c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plexa ProMRI
• Version Model Number: SD 75/18
• Catalog Number: 402264
• 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
• 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

• 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.
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479140007 [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: 2018-04-19

On-Brand Devices [Plexa ProMRI]

• 04035479140014: S 60
• 04035479139971: SD 60/16
• 04035479158798: S DX 65/17
• 04035479158781: S DX 65/15
• 04035479151034: DF-1 S DX 65/17
• 04035479151027: DF-1 S DX 65/15
• 04035479151003: DF-1 SD 65/18
• 04035479140038: S 75
• 04035479140021: S 65
• 04035479140007: SD 75/18
• 04035479139995: SD 65/18