Linox 365501

GUDID 04035479110024

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead

• Primary Device ID: 04035479110024
• NIH Device Record Key: 61613cb4-6fd5-4b19-93de-6df8f7b257e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Linox
• Version Model Number: Smart S DX 65/17
• Catalog Number: 365501
• 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
• 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
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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
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479110024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050023

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: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-08-20

On-Brand Devices [Linox]

• 04035479116194: Smart S 60
• 04035479112998: Smart T 65
• 04035479112981: Smart S 75
• 04035479112974: Smart S 65
• 04035479110024: Smart S DX 65/17
• 04035479110017: Smart S DX 65/15
• 04035479100476: Smart TD 65/18
• 04035479100469: Smart TD 65/16
• 04035479100414: Smart SD 75/18
• 04035479100407: Smart SD 65/18
• 04035479100391: Smart SD 65/16
• 04035479100384: Smart SD 60/16