AccessGUDID - DEVICE: Braincare (07908398200077)

GUDID

Device Identifier (DI) Information

Brand Name: Braincare
Version or Model: BcAc-BATEX-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA

Primary DI Number: 07908398200077
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 903226227 *Terms of Use

Device Description: External Battery of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-BATEX-1000)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16763	Intracranial pressure monitor	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, Monitoring, Intracranial Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201989	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 75.6 Millimeter
Width: 51.5 Millimeter
Height: 14.7 Millimeter

Device Record Status

Public Device Record Key: 63139c6b-1528-421b-a39f-368b5c99027b
Public Version Date: August 21, 2023
Public Version Number: 1
DI Record Publish Date: August 11, 2023