Vivistim®

GUDID 10810041430028

Implantable Pulse Generator

Microtransponder

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

• Primary Device ID: 10810041430028
• NIH Device Record Key: 9c182b84-42b5-46a1-ae42-d913514c2678
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivistim®
• Version Model Number: 1001
• Company DUNS: 793502068
• Company Name: Microtransponder
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810041430028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210007

FDA Product Code

• QPY: Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-09
• Device Publish Date: 2022-04-29

Devices Manufactured by Microtransponder

• 10810041430028 - Vivistim®: 2022-05-09Implantable Pulse Generator
• 10810041430028 - Vivistim®: 2022-05-09 Implantable Pulse Generator
• 10810041430066 - Paired VNS: 2022-05-09 Lead, 2 mm cuff
• 10810041430080 - Paired VNS: 2022-05-09 Lead, 3 mm cuff
• 10810041430004 - Vivistim: 2022-04-05 Stroke Application and Programming Software
• 10810041430042 - Paired VNS: 2022-04-05 Wireless Transmitter
• 10810041430141 - Paired VNS: 2022-04-05 Wireless Transmitter