Corox 355149

GUDID 04035479094164

BIOTRONIK SE & Co. KG

Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead

• Primary Device ID: 04035479094164
• NIH Device Record Key: d6170d6a-4f4b-406b-a6de-8f29995b4dc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corox
• Version Model Number: OTW-S 85-BP
• Catalog Number: 355149
• 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: 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

• 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	04035479094164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P070008

FDA Product Code

• OJX: Drug eluting permanent left ventricular (lv) pacemaker electrode

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-08-06

On-Brand Devices [Corox]

• 04035479112172: OTW-L 85-BP
• 04035479112165: OTW-L 75-BP
• 04035479094164: OTW-S 85-BP
• 04035479094157: OTW-S 75-BP
• 04035479093549: OTW 85-BP
• 04035479093532: OTW 75-BP