VNS Therapy® Programmer, Model 3000 v1.0

GUDID 05425025750399

Programmer

LIVANOVA USA, INC.

Vagus nerve electrical stimulation system programmer

• Primary Device ID: 05425025750399
• NIH Device Record Key: 6ffa77dc-dd0c-4cb8-b487-b29639d0d044
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VNS Therapy® Programmer, Model 3000 v1.0
• 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	05425025750399 [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: 2017-10-06

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