BrainScope One BSO-2001

GUDID 00852745007239

BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the BrainScope One Device.

Brainscope Company, Inc.

Electroencephalograph
Primary Device ID00852745007239
NIH Device Record Key18950102-9a45-4046-b875-6fd0aaddd32a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrainScope One
Version Model NumberAhead 500
Catalog NumberBSO-2001
Company DUNS805670416
Company NameBrainscope Company, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com
Phone240-752-7680
Emailquality@brainscope.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852745007239 [Primary]

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 Date2021-02-24
Device Publish Date2021-02-16

On-Brand Devices [BrainScope One]

0085274500712399-1403-002
00852745007239BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 0085274500722
00852745007284This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ah

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