Home Monitoring Service Center 448494

GUDID 04035479166403

BIOTRONIK SE & Co. KG

Patient health record information system

• Primary Device ID: 04035479166403
• NIH Device Record Key: 5b11e17e-abe9-4f2a-afb4-69f33b2d03db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Home Monitoring Service Center
• Version Model Number: 3.45
• Catalog Number: 448494
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479166403 [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: 2019-09-19
• Device Publish Date: 2019-09-11

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
• 04035479186128: 3.60
• 04035479187163: 3.61
• 04035479184636: 3.59
• 04035479176143: 3.50