Braincare

Primary DI
07908398200008
Brand
Braincare
Company
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
Model
BcSs-PICNI-2000
Device description
Wired Sensor of the Braincare Wired Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcSs-PICNI-2000)
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182073000BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A.2019-10-17GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908398200008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908398200008079083982000087908398200008

GMDN Terms#

Term, Definition table
TermDefinition
Intracranial pressure monitorAn electrically-powered device intended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device (e.g., intracerebral sensor catheter) that transmits electrical signals via connected cables or pressure signals via tubing (e.g., via the air pouch method), or either telemetrically. It may include an alarm designed to alert clinical staff to an elevated ICP and may also produce a strip-chart recording or display of the ICP waveform that enables interpretation of long-term ICP trends.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height40Millimeter
Length70Millimeter
Width20Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1 (424) 888-2942support@brain4.care

Regulatory Flags#

DUNS number
903226227
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07908398200268BraincareBcSs-PICNIW-20002024-08-28
07908398200275BraincareBcAc-AF-20002024-08-28
07908398200282BraincareBcAc-DCK-20002024-08-28
07908398200299BraincareBcAc-CASE-20002024-08-28
07908398200244BraincareBcAc-FU-10002023-09-11
07908398200251BraincareBcAc-AF-1000 + BcAc-FU-10002023-09-11
07908398200060BraincareBcSs-PICNIW-10002023-08-11
07908398200077BraincareBcAc-BATEX-10002023-08-11
07908398200084BraincareBcAc-DCK-10002023-08-11
07908398200091BraincareBcAc-DG-10002023-08-11
07908398200107BraincareBcAc-AF-10002023-08-11
07908398200114BraincareBcAc-AF-10002023-08-11
07908398200121BraincareBcAc-AF-10002023-08-11
07908398200138BraincareBcAc-AF-10002023-08-11
07908398200145BraincareBcAc-AF-10002023-08-11
07908398200152BraincareBcAc-AF-10002023-08-11
07908398200169BraincareBcAc-AF-10002023-08-11
07908398200176BraincareBcAc-AF-10002023-08-11
07908398200183BraincareBcAc-AF-10002023-08-11
07908398200190BraincareBcAc-AF-10002023-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850013266272IRRAflow Cranial Access BoltClearpoint Neuro, Inc.GWM2025-07-24
00763000281243Exacta Pole Clamp with laser levelMEDTRONIC PS MEDICAL, INC.GWM2025-02-17
00763000281229Exacta Pole Clamp with laser levelMEDTRONIC PS MEDICAL, INC.GWM2025-02-16
00763000467401NAMEDTRONIC PS MEDICAL, INC.GWM2024-06-01
00763000406073BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-03-31
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWM2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467382NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467399NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000431259BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529307BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529369BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000572877BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-25
00850013266203IRRAflow Tube SetClearpoint Neuro, Inc.GWM2023-11-02
00763000624774Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624781Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624798Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000428723Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428747Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428754Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428761Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428778Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000431273Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-13
20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395971Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395988N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406004Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406011Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406028Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07