BioGraph Infiniti Advanced Reporting

GUDID 07540191000647

Thought Technology Ltd.

Biofeedback system application software
Primary Device ID07540191000647
NIH Device Record Key3ac358d1-9961-4f9e-ae04-99772cdf0678
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioGraph Infiniti Advanced Reporting
Version Model NumberSA7900AR
Company DUNS209284132
Company NameThought Technology Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS107540191000647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-12-20
Device Publish Date2024-12-12

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