Device
Wired Sensor of the Braincare Wired Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcSs-PICNI-2000)
Manufacturer
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA
Model: BcSs-PICNI-2000
DI: 07908398200008
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
Wired Sensor of the Braincare Wired Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcSs-PICNI-2000)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8b1130b9-d831-4980-a238-2873c11bdd8d
Distribution Status:
In Commercial Distribution
DUNS Number:
903226227
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07908398200008
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16763
Name: Intracranial pressure monitor
Definition:
An 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.
FDA Product Codes
GWM
Device, Monitoring, Intracranial Pressure
Premarket Submissions
Submission Number:
K182073
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
70
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
20
Item #2 - Size Type:
Width
Item #3 - Size - @attributes - Unit:
Millimeter
Item #3 - Size - @attributes - Value:
40
Item #3 - Size Type:
Height
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-25
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
70
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
10
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
90
Item #2 - Storage Handling Type:
Storage Environment Humidity