LV-Kit 383496

GUDID 04035479143473

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: 04035479143473
• NIH Device Record Key: b4ab1dbf-480c-40e2-a489-b20650e3ea47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LV-Kit
• Version Model Number: 75
• Catalog Number: 383496
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains 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 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479143473 [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: 2014-08-19

On-Brand Devices [LV-Kit]

• 04035479143480: 85
• 04035479143473: 75