VNS Therapy® Programmer, Model 3000 v1.0.2

GUDID 05425025750481

Programmer

LIVANOVA USA, INC.

Vagus nerve electrical stimulation system programmer

• Primary Device ID: 05425025750481
• NIH Device Record Key: 10faca55-28fa-448e-aa2b-d48e8c3799be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VNS Therapy® Programmer, Model 3000 v1.0.2
• Version Model Number: 3000
• Company DUNS: 194568978
• Company Name: LIVANOVA USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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@liva

Operating and Storage Conditions

• Storage Environment Temperature: Between -22 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425025750481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970003

FDA Product Code

• LYJ: Stimulator, Autonomic Nerve, Implanted For Epilepsy

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: 2018-02-16

Devices Manufactured by LIVANOVA USA, INC.

• 10803622158701 - Perfusion Pack: 2025-03-05
• 10803622158718 - Perfusion Pack: 2025-03-05
• 10803622158657 - Perfusion Pack: 2025-03-04
• 00803622158667 - Perfusion Pack: 2025-03-04
• 00803622158599 - Perfusion Pack: 2025-03-03
• 00803622158438 - Perfusion Pack: 2025-02-26
• 00803622158445 - Perfusion Pack: 2025-02-26
• 00803622158476 - Perfusion Pack: 2025-02-26