BIOTRONIK

Basic Information

• Brand Name: BIOTRONIK
• Primary DI: 04035479177416
• Version / Model: MyHomeStream 2100.U
• Catalog Number: 469255
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-06
• Public Version: 1
• Public Version Date: 2023-04-14
• Public Version Status: New
• Public Device Record Key: 95a400e5-b1fc-47b9-9c02-edae8f28d119

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGW	Stimulator, spinal-cord, totally implanted for pain relief	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60363	Implantable electrical stimulation device management software	A software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035479177416	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P210037	000