AccessGUDID - DEVICE: Blackrock NeuroPort Biopotential Signal Processing System (00814901021428)

GUDID

Device Identifier (DI) Information

Brand Name: Blackrock NeuroPort Biopotential Signal Processing System
Version or Model: 7.5.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RS-0049
Company Name: BLACKROCK MICROSYSTEMS, LLC

Primary DI Number: 00814901021428
Issuing Agency: GS1
Commercial Distribution End Date: September 02, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 827132015 *Terms of Use

Device Description: NeuroPort Central Suite

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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?
47541	Bioelectrical signal analysis software	A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWL	Amplifier, Physiological Signal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090957	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e5a7764-0fed-4055-8a1a-545e8fd31379
Public Version Date: February 19, 2025
Public Version Number: 2
DI Record Publish Date: August 11, 2022