Neuronaute Plus- Holding Band

GUDID 03615220003983

BIOSERENITY MEDICAL DEVICES GROUP

Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder
Primary Device ID03615220003983
NIH Device Record Keya38aa92b-f480-4980-b584-adbf50fadb87
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuronaute Plus- Holding Band
Version Model Number1001-05001-UN
Company DUNS281224773
Company NameBIOSERENITY MEDICAL DEVICES GROUP
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 Numbertrue
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
GS103615220003983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-29
Device Publish Date2024-03-21

Devices Manufactured by BIOSERENITY MEDICAL DEVICES GROUP

03615220003679 - Neuronaute Plus Touchproof Extender2024-05-30
03615220003983 - Neuronaute Plus- Holding Band2024-03-29
03615220003983 - Neuronaute Plus- Holding Band2024-03-29
03615220003655 - Neuronaute Plus - DB25 Extender2024-02-28
03615220003662 - Neuronaute Plus- IceCap Extender2024-02-28
03615220003990 - Neuronaute Plus - Core Module 2024-02-28
03615220004294 - Neuronaute Mobile Application Android2024-02-28
03615220001026 - Cardioskin Textile S202023-12-28
03615220001033 - Cardioskin Textile S222023-12-28

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