GSR-TMP Combination Sensor (NC-C-GT) - NC-C-GT:The GSR sensor provides a measure of skin - Mind Media B.V.

Duns Number:489837775

Device Description: NC-C-GT:The GSR sensor provides a measure of skin resistance or skin conductance when conn NC-C-GT: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 temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and 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.

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More Product Details

Catalog Number

-

Brand Name

GSR-TMP Combination Sensor (NC-C-GT)

Version/Model Number

1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HCC

Product Code Name

Device, Biofeedback

Device Record Status

Public Device Record Key

b3ffc769-4722-4276-ba55-2dfa43a56b67

Public Version Date

July 27, 2021

Public Version Number

1

DI Record Publish Date

July 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIND MEDIA B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10