AccessGUDID - DEVICE: Galvanic Skin Response Sensor (NB-GSR) (08719481550073)

GUDID

Device Identifier (DI) Information

Brand Name: Galvanic Skin Response Sensor (NB-GSR)
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mind Media Europe B.V.

Primary DI Number: 08719481550073
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 494765181 *Terms of Use

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

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):	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?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 61f839a1-7dec-4f45-9cfe-61368d172ebc
Public Version Date: February 08, 2024
Public Version Number: 2
DI Record Publish Date: July 19, 2021