Vivistim

GUDID 10810041430004

Stroke Application and Programming Software

Microtransponder

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• Primary Device ID: 10810041430004
• NIH Device Record Key: 6995be8a-22cc-452a-a3df-2733a82e5ce6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivistim
• Version Model Number: 4001
• Company DUNS: 793502068
• Company Name: Microtransponder
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	10810041430004 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-05
• Device Publish Date: 2022-03-28

Devices Manufactured by Microtransponder

• 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: 2022-04-05Stroke Application and Programming Software
• 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