Vivistim

Basic Information

• Brand Name: Vivistim
• Primary DI: 10810041430004
• Version / Model: 4001
• Company Name: Microtransponder
• Labeler DUNS: 793502068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-28
• Public Version: 1
• Public Version Date: 2022-04-05
• Public Version Status: New
• Public Device Record Key: 6995be8a-22cc-452a-a3df-2733a82e5ce6

Device Description

Stroke Application and Programming Software

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: Yes
• 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
QPY	Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
44077	Vagus nerve electrical stimulation system programmer	A device intended to be used to change, noninvasively, one or more of the operating parameters (the programs) of an implanted stimulator used for vagus nerve stimulation (VNS). It is able to read stored parameters in the implanted device, providing historic and/or current information regarding device performance. The device is typically an electronic wand with a communication antenna that connects to the port of a personal computer (PC) with dedicated software. The PC will then drive the electronics of the wand to communicate with the implanted stimulation system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810041430004	GS1

Premarket Submissions

Submission Number	Supplement Number
P210007	000