Home Monitoring Service Center 455929

GUDID 04035479169466

BIOTRONIK SE & Co. KG

Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software

• Primary Device ID: 04035479169466
• NIH Device Record Key: 8ee38265-4c7e-47ef-8a4b-57b2bab2a64b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Home Monitoring Service Center
• Version Model Number: 3.49
• Catalog Number: 455929
• 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: false
• Single Use: false
• Lot Batch: true
• 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
• 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
• 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	04035479169466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950037

FDA Product Code

• OSR: Pacemaker/icd/crt non-implanted components

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: 2020-09-18
• Device Publish Date: 2020-09-10

On-Brand Devices [Home Monitoring Service Center]

• 04035479161750: 3.43
• 04035479166106: 3.44
• 04035479166403: 3.45
• 04035479167493: 3.46
• 04035479167509: 3.47
• 04035479168773: 3.48
• 04035479169466: 3.49
• 04035479161743: 3.42
• 04035479158248: 3.38
• 04035479152413: 3.35
• 04035479148867: 3.33
• 04035479148843: 3.31
• 04035479144258: 3.29
• 07640130457300: 3.50
• 04035479175559: 3.51
• 04035479176587: 3.53
• 04035479177942: 3.54
• 04035479179779: 3.55
• 04035479182045: 3.57
• 04035479183264: 3.58