DEVICE: SUDOSCAN® (B122APH20)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GZO | Device, Galvanic Skin Response Measurement |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 41 and 113 Degrees Fahrenheit |
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Handling Environment Temperature: between 65 and 95 Degrees Fahrenheit |
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
99845e7a-3401-41e6-b850-d7698972e10a
August 02, 2022
4
September 09, 2016
August 02, 2022
4
September 09, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(858) 450-2800
sales_us@impeto-medical.com +33(0)143201640
info@impeto-medical.com
sales_us@impeto-medical.com +33(0)143201640
info@impeto-medical.com