Galvanic Skin Response Sensor (NB-GSR)

Basic Information

• Brand Name: Galvanic Skin Response Sensor (NB-GSR)
• Primary DI: 08719481550073
• Version / Model: 1.0
• Company Name: Mind Media Europe B.V.
• Labeler DUNS: 494765181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-19
• Public Version: 2
• Public Version Date: 2024-02-08
• Public Version Status: Update
• Public Device Record Key: 61f839a1-7dec-4f45-9cfe-61368d172ebc

Device Description

NB-GSR: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCC	Device, Biofeedback	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31109	Skin electrical conductance meter	An electronic instrument designed to determine a patient’s electrodermal activity (EDA) [also known as galvanic skin response (GSR), psychogalvanic reflex (PGR), skin conductance response (SCR)] by measuring the electrical conductance of the skin and the tissue path between electrodes placed on the surface of the body (e.g., hands, feet, head), whereby a small electrical current is typically applied. It is used to assess changes in psychophysiological indicators related to autonomic sympathetic activity and emotional states (e.g., fear, startle, pain); sudomotor dysfunction and subsequent reduced EDA have been associated with various conditions (e.g., neuropathy in diabetic patients).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719481550073	GS1