Braincare

Primary DI
07908398200299
Brand
Braincare
Company
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
Model
BcAc-CASE-2000
Device description
Suitcase of Braincare Wireless Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System
Published
2024-08-28
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
K240821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240821000B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.2024-07-18GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908398200299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908398200299079083982002997908398200299

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
Height285Millimeter
Length331Millimeter
Width81Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
903226227
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07908398200008BraincareBcSs-PICNI-20002026-05-08
07908398200268BraincareBcSs-PICNIW-20002024-08-28
07908398200275BraincareBcAc-AF-20002024-08-28
07908398200282BraincareBcAc-DCK-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
07908398200008BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2026-05-08
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