BrainScope One International Charging Kit

Primary DI
00852745007130
Brand
BrainScope One International Charging Kit
Company
BRAINSCOPE COMPANY, INC.
Model
99-1403-028
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLUNormalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLUNormalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161068000Ahead 300Brainscope Company, Inc.2016-09-22PIW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852745007130PackageGS11In Commercial Distribution
00852745007093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852745007130008527450071308527450071300852745007130
00852745007093008527450070938527450070930852745007093

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
240-752-7680sabyasachi.roy@brainscope.com

Regulatory Flags#

DUNS number
805670416
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852745007017Ahead 300 International Charging Kit99-1403-0282018-09-24
00852745007031Ahead Electrode Headset99-1403-2022018-09-24
00852745007062Electrode Headset99-1403-2022018-09-24
00852745007093BrainScope One International Charging Kit99-1403-0282018-09-24
00852745007253Baseline Headset99-1803-202N/A2021-11-15
00852745007284BrainScope OneAhead 500 CUBC1BSO-30012024-06-04
00852745007239BrainScope OneAhead 500BSO-20012021-02-16
00852745007024Ahead 30099-1403-0022018-09-24
00852745007123BrainScope One99-1403-0022018-09-24
00852745007260Baseline Headset99-1803-202N/A2021-11-15
00852745007109Ahead 300 International Charging Kit99-1403-0282018-09-24
00852745007048Ahead Electrode Headset99-1403-2022018-09-24
00852745007079Electrode Headset99-1403-2022018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852745007284BrainScope OneBrainscope Company, Inc.OLU2024-06-04
00852745007253Baseline HeadsetBrainscope Company, Inc.OLU2021-11-15
00852745007260Baseline HeadsetBrainscope Company, Inc.OLU2021-11-15
00852745007239BrainScope OneBrainscope Company, Inc.OLU2021-02-16
EBCI80600cortiQ PROg.tec medical engineering GmbHOLU2020-03-06
00852745007017Ahead 300 International Charging KitBrainscope Company, Inc.OLU2018-09-24
00852745007031Ahead Electrode HeadsetBrainscope Company, Inc.OLU2018-09-24
00852745007062Electrode HeadsetBrainscope Company, Inc.OLU2018-09-24
00852745007093BrainScope One International Charging KitBrainscope Company, Inc.OLU2018-09-24
00852745007109Ahead 300 International Charging KitBRAINSCOPE COMPANY, INC.OLU2018-09-24
00852745007024Ahead 300Brainscope Company, Inc.OLU2018-09-24
00852745007048Ahead Electrode HeadsetBRAINSCOPE COMPANY, INC.OLU2018-09-24
00852745007079Electrode HeadsetBRAINSCOPE COMPANY, INC.OLU2018-09-24
00852745007123BrainScope OneBrainscope Company, Inc.OLU2018-09-24