VNS Therapy® Model 250 v8.1 Programming Software (X5)

Basic Information

• Brand Name: VNS Therapy® Model 250 v8.1 Programming Software (X5)
• Primary DI: 05425025750191
• Version / Model: 250 v8.1 (X5)
• Company Name: LIVANOVA USA, INC.
• Labeler DUNS: 194568978
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f12ed5c2-c455-4626-8f7a-1c321250c7f3

Device Description

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUZ	Stimulator, Autonomic Nerve, Implanted (Depression)	Unknown		3
LYJ	Stimulator, Autonomic Nerve, Implanted For Epilepsy	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	05425025750191	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970003	148

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity