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

Primary DI
08719481550097
Brand
GSR-TMP Combination Sensor (NC-C-GT)
Company
Mind Media Europe B.V.
Model
1.0
Device description
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.
Published
2021-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719481550097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719481550097087194815500978719481550097

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, reusableA temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
494765181
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719481550165NeXus Q241.02025-12-03
08719481550110NeXus 10 MK31.02025-09-10
08719481550400NeXus-Q323.02023-02-08
08719481550349NeXus-10 MKII1.22021-08-13
08719481550080Temperature Sensor (NB-TMP)1.02021-07-19
08719481550004NeXus-Q322.02021-07-19
08719481550035Blood Volume Pulse Sensor (NB-BVP-F)1.02021-07-19
08719481550042Blood Volume Pulse Sensor (NB-BVP-H)1.02021-07-19
08719481550059Blood Volume Pulse Sensor (NC-BVP-F)1.02021-07-19
08719481550066Blood Volume Pulse Sensor (NC-BVP-H)1.02021-07-19
08719481550073Galvanic Skin Response Sensor (NB-GSR)1.02021-07-19
08719481550332NeXus Software1.0.204.62021-07-19

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