AccessGUDID - DEVICE: Blackrock NeuroPort Biopotential Signal Processing System (00814901020100)

GUDID

Device Identifier (DI) Information

Brand Name: Blackrock NeuroPort Biopotential Signal Processing System
Version or Model: 4460
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4460
Company Name: BLACKROCK MICROSYSTEMS, LLC

Primary DI Number: 00814901020100
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 827132015 *Terms of Use

Device Description: Patient Cable with Impedance Tester

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:	Yes
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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	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: Yes
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: 9a3e3c60-bbc4-43c3-9c61-a53ab624b409
Public Version Date: February 10, 2025
Public Version Number: 4
DI Record Publish Date: October 13, 2016