Trigno Wireless Biofeedback System

GUDID 00851679007391

Biofeedback Device

DELSYS, INC.

Psychophysiological biofeedback system

• Primary Device ID: 00851679007391
• NIH Device Record Key: 1803dee0-e78c-4093-8918-55a0aedff115
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trigno Wireless Biofeedback System
• Version Model Number: DS-T04
• 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	00851679007391 [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: 2024-04-22
• Device Publish Date: 2024-04-12

On-Brand Devices [Trigno Wireless Biofeedback System]

• 00851679007209: Biofeedback Device
• 00851679007391: Biofeedback Device