Trigno Centro

GUDID 00851679007377

Biofeedback Device.

DELSYS, INC.

Psychophysiological biofeedback system

• Primary Device ID: 00851679007377
• NIH Device Record Key: 1344c100-b996-4c7d-8e58-29b884ce1fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trigno Centro
• Version Model Number: SP-W10
• 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	00851679007377 [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

Devices Manufactured by DELSYS, INC.

• 00851679007360 - Trigno Avanti Sensor: 2024-05-14 Biofeedback Device
• 00851679007377 - Trigno Centro: 2024-05-14Biofeedback Device.
• 00851679007377 - Trigno Centro: 2024-05-14 Biofeedback Device.
• 00851679007384 - Trigno Charge-16: 2024-05-14 Biofeedback Device.
• 00851679007407 - Trigno Avanti Sensor, 4-Pack: 2024-05-14 Biofeedback Device
• 00851679007391 - Trigno Wireless Biofeedback System: 2024-04-22 Biofeedback Device
• 00851679007353 - Trigno Maize Sensor: 2020-12-31 Trigno Wireless Biofeedback System component.
• 00851679007346 - Trigno Avanti Duo Sensor: 2020-02-03 Trigno System Component
• 00851679007339 - Trigno Avanti EKG Biofeedback Sensor: 2019-10-31 Trigno System Component