FDA.reportPublic FDA data

Braincare

Primary DI
07908398200237
Brand
Braincare
Company
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
Model
BcAc-AF-1000
Device description
Headband 2 of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-AF-1000)
Published
2023-08-11
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
K201989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201989000B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.2021-10-08GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908398200237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908398200237079083982002377908398200237

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length540Millimeter
Width20Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius45 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
Lot or batch
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701813000023Catheter Extension CableSOPHYSAGWM2026-10-27
03701813000030PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03701813000054Catheter Extension CableSOPHYSAGWM2026-10-27
03760409441510PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03760409441527PRESSIO®3 - PATIENT MONITOR CABLE PHILIPS, AGILENT, MINDRAY 12 pinsSOPHYSAGWM2026-10-27
03760409441534PRESSIO®3 - PATIENT MONITOR CABLE DRAEGER, SIEMENS 10 pinsSOPHYSAGWM2026-10-27
03760409441541PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB, MINDRAY 6 pinsSOPHYSAGWM2026-10-27
03760409441558PRESSIO®3 - PATIENT MONITOR CABLE GE DATEX OHMEDA 10 pinsSOPHYSAGWM2026-10-27
03760409441565PRESSIO®3 - PATIENT MONITOR CABLE GE SOLAR, MARQUETTE 11 pinsSOPHYSAGWM2026-10-27
03760409441572PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 5 pinsSOPHYSAGWM2026-10-27
03760409441589PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE PHILIPS, AGILENT 2 pinsSOPHYSAGWM2026-10-27
03760409441596PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DRAEGER, SIEMENS 7 pinsSOPHYSAGWM2026-10-27
03760409441602PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409441619PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE GE SOLAR, MARQUETTE, DATEX-OHMEDASOPHYSAGWM2026-10-27
03760409441626PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DATEX-OHMEDA, NIHON KOHDEN, MINDRASOPHYSAGWM2026-10-27
03760409441633PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE ARTIC SUNSOPHYSAGWM2026-10-27
03760409441640PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE PHILIPS Jack 3,5mmSOPHYSAGWM2026-10-27
03760409441657PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE DRAEGER INFINITYSOPHYSAGWM2026-10-27
03760409441671PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE without patient data moduleSOPHYSAGWM2026-10-27
03760409441688PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE CARESCAPE & GE with patient data moduSOPHYSAGWM2026-10-27
03760409441695PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW T6 & UMEC SERIES 8, 10,SOPHYSAGWM2026-10-27
03760409441701PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY PASSPORT 8, 12 & EPM 10, 12SOPHYSAGWM2026-10-27
03760409441718PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW N1, N12, N15, N17, N19,SOPHYSAGWM2026-10-27
03760409441725PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT, LIFE SCOPE VSOPHYSAGWM2026-10-27
03760409441732PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT with YJ-920PSOPHYSAGWM2026-10-27
03760409441749PRESSIO®3 - MULTI-PARAMETER NEUROMONITOR ICP, ICT, CPPSOPHYSAGWM2026-10-27
03760409442074PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409442081PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 14 pinsSOPHYSAGWM2026-10-27
03760409442098PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 12 pinsSOPHYSAGWM2026-10-27
03760409442104PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 11 pinsSOPHYSAGWM2026-10-27