Trigno Avanti Duo Sensor

GUDID 00851679007346

Trigno System Component

DELSYS, INC.

Psychophysiological biofeedback system
Primary Device ID00851679007346
NIH Device Record Keye1b94054-1ec2-4496-9b16-0da869afbcea
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrigno Avanti Duo Sensor
Version Model NumberSP-W06-027
Company DUNS826428344
Company NameDELSYS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851679007346 [Primary]

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-03
Device Publish Date2020-01-24

Devices Manufactured by DELSYS, INC.

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00851679007407 - Trigno Avanti Sensor, 4-Pack2024-05-14 Biofeedback Device
00851679007391 - Trigno Wireless Biofeedback System2024-04-22 Biofeedback Device
00851679007353 - Trigno Maize Sensor2020-12-31 Trigno Wireless Biofeedback System component.
00851679007346 - Trigno Avanti Duo Sensor2020-02-03Trigno System Component
00851679007346 - Trigno Avanti Duo Sensor2020-02-03 Trigno System Component
00851679007339 - Trigno Avanti EKG Biofeedback Sensor2019-10-31 Trigno System Component

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