SUDOSCAN® ADSPHD
GUDID B122ADSPHD0
SUDOSCAN S device consists of the following Hand Smart Electrodes Dock Foot Smart Electrodes Dock Smart Electrodes USB cable A software application
IMPETO MEDICAL
Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter Skin electrical conductance meter| Primary Device ID | B122ADSPHD0 |
| NIH Device Record Key | 58bdcae8-49ee-4925-ac20-671c20002ed0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUDOSCAN® |
| Version Model Number | SUDOSCAN S |
| Catalog Number | ADSPHD |
| Company DUNS | 279502673 |
| Company Name | IMPETO MEDICAL |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B122ADSPHD0 [Primary] |
FDA Product Code
| GZO | Device, Galvanic Skin Response Measurement |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2019-05-13 |
On-Brand Devices [SUDOSCAN®]
| B122S2MU0 | SUDOSCAN2 Master unit |
| B122DSP0 | Smart electrodes |
| B122APH20 | Hand electrodes standard |
| B122APF20 | Foot electrodes standard |
| B122ADSPHD0 | SUDOSCAN S device consists of the following Hand Smart Electrodes Dock Foot Smart Electrodes D |
Trademark Results [SUDOSCAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUDOSCAN 79100037 4181325 Live/Registered |
IMPETO MEDICAL 2011-05-25 |
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