DEVICE: SUDOSCAN® (B122S2MU0)

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Device Identifier (DI) Information

SUDOSCAN®
SUDOSCAN2
S2MU
IMPETO MEDICAL
B122S2MU0
HIBCC
1
SUDOSCAN2 Master unit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Skin electrical conductivity meter An electronic instrument designed to determine autonomic responses as psychological indicators (e.g., for fear, anger, startle) by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. This phenomenon is known as the galvanic skin response (GSR), electrodermal response (EDR), psychogalvanic reflex (PGR), or skin conductance response (SCR).
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FDA Product Code

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Product Code Product Code Name
GZO Device, Galvanic Skin Response Measurement
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 09, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
(858) 450-2800
sales_us@impeto-medical.com
+33(0)143201640
info@impeto-medical.com
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