DH IS-1/DF4 401298

GUDID 04035479138523

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: 04035479138523
• NIH Device Record Key: 7b7459fc-5ec9-401b-a720-f812b96093d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DH IS-1/DF4
• Version Model Number: 401298
• Catalog Number: 401298
• Company DUNS: 315620229
• Company Name: BIOTRONIK SE & Co. KG
• Device Count: 2
• 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479138523 [Package]; Contains: 04035479146160; Package: case [5 Units]; In Commercial Distribution
GS1	04035479146160 [Primary]
GS1	04035479158118 [Unit of Use]

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: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2017-03-27

On-Brand Devices [DH IS-1/DF4]

• 04035479138523: 401298
• 04035479138516: 401297