VNS Therapy® PerenniaFLEX® Model 304 Lead

GUDID 05425025750139

Implantable Lead

LIVANOVA USA, INC.

Vagus nerve electrical stimulation system lead

• Primary Device ID: 05425025750139
• NIH Device Record Key: 49bd6777-9579-4d84-8095-302e5f8c5d82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VNS Therapy® PerenniaFLEX® Model 304 Lead
• Version Model Number: 304-20
• Company DUNS: 194568978
• Company Name: LIVANOVA USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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

Device Dimensions

• Outer Diameter: 2 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425025750139 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-17

On-Brand Devices [VNS Therapy® PerenniaFLEX® Model 304 Lead]

• 05425025750153: Implantable Lead
• 05425025750139: Implantable Lead