Trigno Avanti Sensor

GUDID 00851679007360

Biofeedback Device

DELSYS, INC.

Psychophysiological biofeedback system

• Primary Device ID: 00851679007360
• NIH Device Record Key: 79d6b465-c10a-43f6-a83e-e2b3edc53060
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trigno Avanti Sensor
• Version Model Number: SP-W11
• Company DUNS: 826428344
• Company Name: DELSYS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851679007360 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [Trigno Avanti Sensor]

• 00851679007216: Trigno System Component
• 00851679007360: Biofeedback Device