VNS Therapy® Model 250 v11.0 Programming Software

GUDID 05425025750368

Programming Software

LIVANOVA USA, INC.

Vagus nerve electrical stimulation system programmer

• Primary Device ID: 05425025750368
• NIH Device Record Key: 593bfcd4-dec1-4cb1-991b-86204ef664ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VNS Therapy® Model 250 v11.0 Programming Software
• Version Model Number: 250 v11.0
• Company DUNS: 194568978
• Company Name: LIVANOVA USA, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 (866) 882-8804
• Email: ClinicalTechnicalServices@cybe

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425025750368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970003

FDA Product Code

• MUZ: Stimulator, Autonomic Nerve, Implanted (Depression)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-02

On-Brand Devices [VNS Therapy® Model 250 v11.0 Programming Software]

• 05425025750375: Programming Software
• 05425025750368: Programming Software