PatientApp 2.9 496395

GUDID 04035479189211

BIOTRONIK SE & Co. KG

Implantable cardiac device management application software

• Primary Device ID: 04035479189211
• NIH Device Record Key: c64c3b58-ea9a-4ab4-8cb7-c55d146116e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PatientApp 2.9
• Version Model Number: 496395
• Catalog Number: 496395
• Company DUNS: 315620229
• Company Name: BIOTRONIK SE & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479189211 [Primary]

FDA Product Code

• OUG: Medical device data system

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-12
• Device Publish Date: 2026-03-04

Devices Manufactured by BIOTRONIK SE & Co. KG

• 04035479189211 - PatientApp 2.9: 2026-03-12
• 04035479189211 - PatientApp 2.9: 2026-03-12
• 04035479177041 - Solia CSP S 60: 2026-02-25
• 04035479177058 - Solia CSP S 53: 2026-02-25
• 04035479189235 - SW HMSC 3.65: 2026-01-28
• 04035479188689 - SW HMSC 3.63: 2025-05-15
• 04035479179687 - NEO: 2025-04-11
• 04035479179694 - PSW: 2025-04-11
• 04035479185817 - Neuro CP app 2300.U: 2025-04-04