Ahead Electrode Headset

GUDID 00852745007048

BRAINSCOPE COMPANY, INC.

Electroencephalographic electrode cap, single-use
Primary Device ID00852745007048
NIH Device Record Keyafaf9870-8140-4f1f-bca5-ab5da95e7138
Commercial Distribution StatusIn Commercial Distribution
Brand NameAhead Electrode Headset
Version Model Number99-1403-202
Company DUNS805670416
Company NameBRAINSCOPE COMPANY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com
Phone240-752-7680
Emailsabyasachi.roy@brainscope.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852745007031 [Primary]
GS100852745007048 [Package]
Contains: 00852745007031
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLUNormalizing Quantitative Electroencephalograph Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

Devices Manufactured by BRAINSCOPE COMPANY, INC.

00852745007284 - BrainScope One2024-06-12 This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ahead 500 CUBC1 Kit. Contains Devi
00852745007260 - Baseline Headset2021-11-23 A variant of the electrode headset that is to be used for Baseline sessions.
00852745007239 - BrainScope One2021-02-24 BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the Brain
00852745007109 - Ahead 300 International Charging Kit2020-02-06
00852745007130 - BrainScope One International Charging Kit2020-02-06
00852745007024 - Ahead 3002018-10-25
00852745007048 - Ahead Electrode Headset2018-10-25
00852745007048 - Ahead Electrode Headset2018-10-25
00852745007079 - Electrode Headset2018-10-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.